Breast pump system and components and uses thereof

ABSTRACT

The present disclosure provides improved breast pump systems, components thereof, and methods of use thereof. The breast pump system includes a breast cup having a diaphragm disposed between a pressure chamber and milk chamber. Expansion and contraction of the diaphragm acts to express milk and transport it from the breast cup.

BACKGROUND OF THE INVENTION

Many new mothers use breast pumps post-birth in order to achieve their personal milk feeding and expression goals. Breast pumps systems draw breast milk from a breast of a user and may be used to pump breast milk for later consumption by an infant, to stimulate lactation in users with low milk supply, or to relieve engorgement. Breast pumps may be manually operated, for example by squeezing a handle or operation of a foot pedal. Breast pumps may also be electrically driven by a drive unit.

On average, new mothers feed their infants more than 12 times per day, with newborn infants needing to be fed every two to three hours. Mothers may spend more than four hours each day breastfeeding, on average spending 20 minutes out of every two hours breastfeeding, interrupting work, social, and sleep schedules. The demands of breastfeeding and pumping require mothers to wake up throughout the night drastically decreasing the total hours of sleep per night a mother is able to achieve. Such sleep loss contributes to a number of conditions in women, such as mastitis and postpartum depression.

There are no commercially available breast pump systems configured for serial breast pumping sessions without removal of a breast cup or without replacement of a reservoir in the system. Further, there are no commercially available breast pump systems configured for efficacious breast pumping while resting and sleeping. Thus, there is a continuing need for comfortable, wearable breast pump systems that are simple to use and allow the user to pump while navigating daily activities, resting, or sleeping.

SUMMARY OF THE INVENTION

The present disclosure provides improved breast pumps, components thereof, and methods of use thereof.

In one aspect, the invention provides a breast cup including (a) a housing; (b) a breast shield; and (c) a diaphragm disposed between the housing and the breast shield. The diaphragm is disposed between a pressure chamber and a milk chamber.

In some embodiments, the breast shield includes a wide portion and a nipple tunnel.

In some embodiments, the breast cup further includes a milk chamber wall disposed between the diaphragm and the breast shield. The diaphragm and the milk chamber wall define the milk chamber.

In some embodiments, the milk chamber includes an inlet from the breast shield, and the diaphragm releasably seals the inlet. In some embodiments, the inlet includes a valve, e.g., a mechanical valve, an umbrella valve, a butterfly valve, a disk valve, or a duckbill valve. In some embodiments, the inlet comprises a plurality of orifices. In some embodiments, the plurality of orifices is circumferentially arranged at a nipple tunnel of the breast shield.

In some embodiments, the breast shield and/or the housing includes ridges, bumps or dimples. In some embodiments, the breast shield includes a toroidal ridge.

In some embodiments, the diaphragm includes a material having a shore harness from A10 to A80 or D10 to D80. In some embodiments, the diaphragm includes a first material and a second material, where the second material is more rigid than the first material and seals the inlet.

In some embodiments, the housing, diaphragm, and/or breast shield includes a clear material. In some embodiments, the clear material forms a magnifying lens. In some embodiments, the diaphragm includes the clear material where the diaphragm contacts an inlet to the milk chamber.

In some embodiments, the diaphragm is shaped to conform to the shape of the housing or breast shield.

In some embodiments, the milk chamber further comprises an outlet.

In some embodiments, the breast cup further includes a one directional valve configured to allow fluid flow from the milk chamber to a reservoir. In some embodiments, the one directional valve is disposed in the outlet.

The present invention provides a breast pump system including: (a) a breast cup as described herein; (b) a negative pressure source, wherein the negative pressure source is in fluidic communication with the pressure chamber; and (c) optionally a reservoir in fluidic communication with the milk chamber. In some embodiments, the system includes the reservoir.

In some embodiments, the breast pump system further includes a positive pressure source, wherein the positive pressure source is in fluidic communication with the pressure chamber. In some embodiments, the positive pressure source is a vacuum pump. In some embodiments, a pressure source includes the negative pressure source and the positive pressure source. In some embodiments, the negative pressure source is a vacuum pump.

In some embodiments, the breast pump system further includes a first fluid conduit providing fluidic communication between the milk chamber and the reservoir. In some embodiments, the first fluid conduit is releasably connected to the milk chamber and/or the reservoir. In some embodiments, the first fluid conduit includes a movement element. In some embodiments, the movement element includes a swivel fitting or a rotating fitting. In some embodiments, the movement element includes a ball bearing. In some embodiments, the first fluid conduit is movably connected to the milk chamber. In some embodiments, the first fluid conduit is rotatable with respect to the breast cup.

In some embodiments, the breast pump system further includes a second fluid conduit providing fluidic communication between the negative pressure source and/or the positive pressure source and the pressure chamber. In some embodiments, the second fluid conduit is releasably connected to the negative pressure source, the positive pressure source, and/or the pressure chamber.

In some embodiments, the breast pump system further includes a control valve.

In some embodiments, the milk chamber further includes an outlet.

In some embodiments, the breast pump system further includes a one directional valve configured to allow fluid flow from the milk chamber to the reservoir. In some embodiments, the one directional valve is disposed in the first fluid conduit. In some embodiments, the outlet includes the one directional valve. In some embodiments, the one directional valve is disposed in the diaphragm.

In some embodiments, the breast shield is configured to include a slow leak to the ambient atmosphere.

In some embodiments, the breast shield includes a wide portion and a nipple tunnel. In some embodiments, the nipple tunnel has a length from about 5 mm to about 75 mm (e.g., about 5 mm to about 25 mm, about 10 mm to about 30 mm, about 25 mm to about 50 mm, about 30 mm to about 60 mm, or about 50 mm to about 75 mm). In some embodiments, the nipple tunnel has a minimum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 100 mm, about 75 mm to about 100 mm, or about 100 mm to about 130 mm). In some embodiments, the nipple tunnel has a maximum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 100 mm, about 75 mm to about 100 mm, or about 100 mm to about 130 mm). In some embodiments, the diameter of the nipple tunnel is between about 20 and about 40 mm.

In some embodiments, the breast shield is funneled.

In some embodiments, the milk chamber includes a volume from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 50 mL, about 10 mL to about 50 mL, about 25 mL to about 50 mL, about 30 mL to about 60 mL, about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 75 mL to about 125 mL or about 100 mL to about 150 mL). In some embodiments, the pressure chamber includes a volume from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 50 mL, about 10 mL to about 50 mL, about 25 mL to about 50 mL, about 30 mL to about 60 mL, about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 75 mL to about 125 mL or about 100 mL to about 150 mL).

In some embodiments, the breast pump system further includes a milk chamber wall disposed between the diaphragm and the breast shield, and the diaphragm and the milk chamber wall define the volume of the milk chamber.

In some embodiments, the milk chamber includes an inlet from the breast shield, e.g., wherein the diaphragm releasably contacts the inlet. In some embodiments, the diaphragm releasably seals the inlet.

In some embodiments, the inlet includes a valve. In some embodiments, the valve is mechanical valve, an umbrella valve, a butterfly valve, a disk valve, or a duckbill valve.

In some embodiments, the inlet includes a plurality of orifices. In some embodiments, the plurality of orifices is circumferentially arranged at the nipple tunnel of the breast shield. In some embodiments, each of the plurality of orifices has a diameter from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 2.5 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm).

In some embodiments, the breast cup or component thereof, e.g., the breast shield, includes a flexible material. In some embodiments, the breast cup or component thereof, e.g., the breast shield, is polymeric. In some embodiments, the housing includes polyethylene terephthalate (PET), polypropylene (PP), polytetrafluoroethylene (PTFE) (e.g., Teflon), polyethylene, high-density polyethylene (HDPE), low-density polyethylene (LDPE), copolyester (e.g., Tritan EX401), polycarbonate (PC), nylon, polyvinylidene fluoride (PVDF), silicon, polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill.

In some embodiments, the breast cup or component thereof, e.g., the breast shield, include ridges, bumps or dimples. In some embodiments, the breast cup includes a toroidal ridge.

In some embodiments, the breast pump system further includes two breast cups, wherein the two breast cups each include a housing, a breast shield, and a diaphragm as described herein.

In some embodiments, the diaphragm includes a flexible material. In some embodiments, the diaphragm includes a polymeric material.

In some embodiments, the diaphragm includes a material having a shore hardness from Al 0 to A80. In some embodiments, the diaphragm includes a material having a shore hardness from Al 0 to A80 and a second shore hardness from Al 0 to A80 or being rigid, wherein the material includes the second shore hardness or is rigid where the diaphragm contacts the inlet. In some embodiments, the diaphragm includes a first material, e.g., having a shore hardness from Al 0 to A80, and a second material, e.g., having a different shore hardness from Al 0 to A80 or being rigid. In some embodiments, either the first or second material may have a shore hardness from D10 to D80. The second material may be more rigid than the first material and contact the inlet.

In some embodiments, the diaphragm includes a thickness from about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm). In some embodiments, the diaphragm includes a first thickness from about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm), and a second thickness from about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm), wherein the diaphragm includes the second thickness where the diaphragm contacts the inlet. The thickness of the diaphragm may be non-uniform. For example, portions at the edge or contacting the inlet may be thicker or thinner than other portions.

In some embodiments, the diaphragm includes a plurality of layers. In some embodiments, the diaphragm includes a plurality of layers wherein the diaphragm contacts the inlet.

In some embodiments, the diaphragm is shaped to conform to the shape of breast shield or the milk chamber wall. In some embodiments, the diaphragm includes a curved shape.

In some embodiments, the pressure chamber further includes a valve to the ambient atmosphere.

In some embodiments, a volume of the pressure chamber may be set with the valve. In some embodiments, the valve is an inflation valve.

All or portions of the breast cup may be clear, e.g., to allow for visualization of the nipple during placement of the breast cup. A portion, e.g., a portion of the diaphragm, may also include a lens to magnify the nipple for alignment. Breast cups with clear portions may include a flap or other opaque covering to hide the clear portions after alignment.

In some embodiments, the breast pump system further includes a plurality of reservoirs.

In some embodiments, each reservoir includes a pressure sensor.

In some embodiments, each reservoir includes a weight sensor, e.g., a scale.

In some embodiments, the breast pump system further includes a pressure outlet in fluidic communication with each reservoir. In some embodiments, each pressure outlet includes a valve. In some embodiments, the pressure outlet is a breather tube.

In some embodiments, the breast pump system further includes a manifold disposed between the milk chamber and the plurality of reservoirs. In some embodiments, the manifold includes a straight manifold, a right-angle manifold, a round manifold, a block manifold, a square manifold, a hex manifold, a wye manifold, or a rotating joint manifold.

In some embodiments, the manifold includes a valve.

In some embodiments, the manifold includes an inlet and an outlet that is configured to move from a first position to a second position, e.g., to provide fluidic communication with two different reservoirs.

In some embodiments, the outlet of the manifold is configured to be in fluidic communication with one reservoir at a time.

In some embodiments, the manifold includes a plurality of outlets. In some embodiments, each reservoir includes an inlet in fluidic communication with a different outlet of the manifold. In some embodiments, each outlet includes a valve. In some embodiments, the valve is a solenoid valve.

In some embodiments, the manifold includes (i) a movable, e.g., rotating, member including the inlet of the manifold and a fluid conduit, wherein the inlet of the manifold and the fluid conduit are in fluidic communication, and (ii) a stationary member including the plurality of outlets of the manifold. In some embodiments, the movable, e.g., rotating, member is configured to move, e.g., rotate, and align the fluid conduit with each of the plurality of outlets of the manifold. In some embodiments, the movable, e.g., rotating, member is axially arranged within the stationary member.

In some embodiments, the breast pump system further includes a drive unit operatively connected to the negative pressure source and/or the positive pressure source. In some embodiments, the drive unit includes the control unit.

In some embodiments, the breast pump system further includes a power source. In some embodiments, the breast pump system further includes a display, timer, alarm, and/or power switch.

In some embodiments, the breast pump system further includes a sensor selected from the group consisting of a weight sensor, a load cell, a temperature sensor, a pressure sensor, an optical sensor, a flow sensor, a volume sensor, a pH sensor, and a viscosity sensor. In some embodiments, a single weight sensor, e.g., a scale, is employed for multiple reservoirs, e.g., all reservoirs.

In some embodiments, the breast pump system further includes a garment, and the breast cup is releasably secured to the garment. In some embodiments, the garment is a bra or shirt. In some embodiments, the coefficient of friction between the garment and the housing is less than 0.4 (e.g., 0.3, 0.2, 0.1, or 0.5).

In some embodiments, the breast pump system further includes an enclosure. In some embodiments, the enclosure includes a cooling element and/or insulation. In some embodiments, the enclosure includes a pillow.

The present invention provides a method of breast pumping including: providing the breast pump system of the present disclosure, contacting a human breast of a subject with the breast cup; and pumping milk from the human breast by alternating reducing and increasing pressure in the pressure chamber.

In some embodiments, the subject is moving, resting, or sleeping. In some embodiments, the subject is moving, reclining, resting, or sleeping.

In some embodiments, the method further includes connecting the second fluid conduit to the breast cup and negative pressure source and/or positive pressure source. In some embodiments, the method further includes connecting the first fluid conduit to the breast cup and the reservoir. In some embodiments, the method further includes connecting the second fluid conduit to the negative pressure source and the pressure chamber. In some embodiments, the method further includes connecting the third fluid conduit to the control valve, the breast cup, and/or the second fluid conduit. In some embodiments, the method further includes connecting the fourth fluid conduit to the breast cup and the reservoir.

In some embodiments, the method further includes contacting the human breast with the wide portion of the breast cup. In some embodiments, the method further includes contacting the human breast with the wide portion of the breast shield. In some embodiments, a nipple of the breast is placed in the nipple tunnel of the breast cup. In some embodiments, the method further includes contacting two human breasts with the two breast cups.

In some embodiments, the method further includes applying negative pressure to the pressure chamber with the negative pressure source. In some embodiments, the method further includes deforming the diaphragm away from the breast shield. In some embodiments, the method further includes deforming the diaphragm away from the inlet. In some embodiments, the milk chamber comprises an inlet, and the diaphragm pulls away from the inlet to provide fluidic communication between the milk chamber and the breast shield when pressure in the pressure chamber is reduced. In some embodiments, the method further includes unsealing the inlet. In some embodiments, the method further includes expanding the milk chamber. In some embodiments, the method further includes contracting the pressure chamber. In some embodiments, the method further includes providing negative pressure to elongate the nipple. In some embodiments, the method further includes drawing milk from the nipple. In some embodiments, the method further includes drawing milk from the nipple tunnel into the milk chamber. In some embodiments, the method further includes drawing milk through the inlet into the milk chamber.

In some embodiments, the method further includes opening the control valve and depressurizing the pressure chamber. In some embodiments, the method further includes returning the diaphragm to a nominal position. In some embodiments, the method further includes closing the control valve.

In some embodiments, the method further includes applying positive pressure to the pressure chamber with the positive pressure source. In some embodiments, the method further includes allowing the nipple to contract. In some embodiments, the method further includes deforming the diaphragm towards the breast shield. In some embodiments, the method includes allowing the diaphragm to return to a nominal position. In some embodiments, the method further includes sealing the inlet with the diaphragm. In some embodiments, the diaphragm seals the inlet when pressure in the pressure chamber increases. In some embodiments, the method further includes sealing orifices in the inlet with the diaphragm. In some embodiments, the method further includes contracting the milk chamber. In some embodiments, the method further includes expanding the pressure chamber. In some embodiments, the method further includes transporting milk from the milk chamber through the first fluid conduit to the reservoir. In some embodiments, the method further includes transporting milk through the outlet. In some embodiments, the method further includes transporting milk through the one directional valve.

In some embodiments, the method further includes applying negative pressure to a fluid conduit attached to an outlet of the milk chamber. In some embodiments, the negative pressure is applied via a peristaltic pump or a vacuum pump. In some embodiments, the fluid conduit comprises an air inlet.

In some embodiments, the method further includes waiting at least 30 minutes after the pumping step and repeating the pumping step to a provide a first and second breast pumping session. In some embodiments, the method further includes pumping milk from the human breast twice, wherein there is at least about 30 minutes (e.g., about 45 minutes, about 60 minutes, about 75 minutes, about 90 minutes, about 120 minutes, about 150 minutes, about 180 minutes, about 210 minutes, or about 240 minutes) between a first breast pumping session to a second breast pumping session.

In some embodiments, milk from the first breast pumping session is transported to a first reservoir, and milk from the second breast pumping session is transported to a second reservoir, e.g., via a manifold. In some embodiments, the manifold directs milk to the first reservoir and the second reservoir by moving a movable member to provide sequential fluidic communication between an inlet to the manifold and the first and second reservoirs.

In some embodiments, the method further includes pumping milk from the human breast to induce milk from a first breast pumping session to flow from a nipple to the manifold via the breast cup; providing fluidic communication between the inlet of the manifold and a first reservoir to allow milk from the first breast pumping session to flow into the first reservoir; removing fluidic communication between the inlet of the manifold and the first fluid reservoir; pumping the human breast to induce milk from a second breast pumping session to flow from the nipple to the manifold via the breast cup; and providing fluidic communication between the inlet of the manifold and a second reservoir to allow milk from the second breast pumping session to flow into the second reservoir. In some embodiments, the method further includes from 30 minutes to 240 minutes (about 30 minutes to 60 minutes, about 30 minutes to 90 minutes, about 60 minutes to about 180 minutes, about 60 minutes to about 120 minutes, about 90 minutes to 120 minutes, or about 120 minutes to 240 minutes) between the first and second sessions.

In some embodiments, the method further includes removing fluidic communication between the inlet of the manifold and the second fluid reservoir; providing fluidic communication between the inlet of the manifold and a third reservoir; and pumping the human breast to induce milk from a third breast pumping session to flow from the nipple to the manifold via the breast cup. In some embodiments, the method further includes from 30 minutes to 240 minutes (about 30 minutes to 60 minutes, about 30 minutes to 90 minutes, about 60 minutes to about 180 minutes, about 60 minutes to about 120 minutes, about 90 minutes to 120 minutes, or about 120 minutes to 240 minutes) between step the second and third sessions.

In some embodiments, the method further includes providing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by moving the movable, e.g., rotating, member. In some embodiments, the method further includes removing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by moving, e.g., rotating, the movable, e.g., rotating, member.

In some embodiments, the method further includes providing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by opening the valve to the inlet of the first reservoir, the second reservoir, or the third fluid reservoir. In some embodiments, the method further includes removing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by closing the valve to the inlet of the first reservoir, the second reservoir, or the third fluid reservoir.

In some embodiments, the method further includes providing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by moving the arm. In some embodiments, the method further includes removing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by moving the arm. In some embodiments, the method further includes moving the arm with the drive unit, wherein the drive unit is the stepper motor.

In some embodiments, the method further includes taking a weight, a temperature, a pressure, an optical, a flow rate, a pH, or a viscosity measurement of the milk with the sensor. In some embodiments, the method further includes alerting a user of the temperature, pressure, optical, flow rate, volume, pH, or viscosity measurement. In some embodiments, the method further includes changing at least one of the first pressure or second pressure based on the temperature, pressure, or flow rate measurement. In some embodiments, the method further includes measuring the weight of a reservoir containing the pumped milk.

In some embodiments, the method further includes securing the breast cup to the garment and donning the garment. In some embodiments, the method further includes donning the garment and securing the breast cup to the garment.

In some embodiments, the method further includes using the enclosure as a pillow.

In some embodiments, the method further includes pumping milk from the human breast at least twice without removing the breast cup from the human breast.

The present disclosure provides a method of cleaning a breast pump system: (i) providing the breast pump system of the present disclosure, (ii) providing a cleaning fluid to the breast cup; and (iii) pumping the cleaning fluid from the breast cup to the reservoir.

In some embodiments, the breast pump system includes a breast milk distribution system as described herein.

In some embodiments, the breast milk distribution system further includes a plurality of reservoirs, wherein each of the plurality of reservoirs are configured to be in fluidic communication with a different outlet. In some embodiments, the breast milk distribution system further includes from 2 to 12 reservoirs. In some embodiments, the breast milk distribution system further includes from 4 to 6 reservoirs.

In some embodiments, each reservoir includes a pressure sensor.

In some embodiments, the breast milk distribution system further includes a pressure outlet in fluidic communication with each reservoir. In some embodiments, each pressure outlet includes a valve. In some embodiments, the pressure outlet is a breather tube.

In some embodiments, each reservoir includes an inlet in fluidic communication with a different outlet of the manifold. In some embodiments, the inlet of the reservoir is configured to open and close.

In some embodiments, the breast milk distribution system further includes a plurality of valves, wherein the inlet of each reservoir includes a valve, e.g., to seal each inlet when not being filled.

In some embodiments, each reservoir includes a lid, wherein lid includes the pressure outlet, the inlet of the reservoir, and/or the valve of the reservoir.

In some embodiments, the breast milk distribution system further includes a pressure source in fluidic communication with the breast cup, the manifold, and/or at least one of the plurality of reservoirs. In some embodiments, the pressure source is a negative pressure source or a positive pressure source. In some embodiments, the pressure source is configured to open and/close an outlet of the manifold. In some embodiments, the pressure source is configured to open and/close an inlet of a reservoir.

In some embodiments, the breast cup includes (i) a housing; (ii) a breast shield; and (iii) a diaphragm disposed between the housing and the breast shield, wherein the diaphragm is further disposed between a pressure chamber and a milk chamber. In some embodiments, the negative pressure source is fluidic communication with the pressure chamber. In some embodiments, the plurality of reservoirs is configured to be in fluidic communication with the milk chamber.

In some embodiments, the manifold includes a straight manifold, a right-angle manifold, a round manifold, a block manifold, a square manifold, a hex manifold, a wye manifold, or a rotating joint manifold.

In some embodiments, the manifold includes (i) a moving, e.g., rotating, member including the inlet of the manifold and a fluid conduit, wherein the inlet of the manifold and the fluid conduit are in fluidic communication, and (ii) a stationary member including the plurality of outlets of the manifold. In some embodiments, the moving, e.g., rotating, member is configured to move, e.g., rotate, and align the fluid conduit with each of the plurality of outlets of the manifold.

In some embodiments, the fluid conduit of the moving, e.g., rotating, member includes an outlet, and the diameter of the outlet of the fluid conduit has the same diameter as the outlets of the manifold. In some embodiments, the diameter of the outlet of the fluid conduit is larger than the diameter of the outlets of the manifold. In some embodiments, the diameter of the outlet of the fluid conduit is smaller than the diameter of the outlets of the manifold.

In some embodiments, the outlets of the manifold are radially disposed in the stationary member.

In some embodiments, the inlet of the manifold has a longitudinal axis orthogonally arranged to a longitudinal axis of each of the outlets of the manifold.

In some embodiments, each of outlets of the manifold includes a valve. In some embodiments, the valve includes a ball valve, a batch dispensing valve, a butterfly valve, a diaphragm valve, a diverting valve, a gate valve, a piston valve, a plug valve, a pinch valve, a saddle valve, a solenoid valve, a stem valve, a stop cock valve, or a three-way valve. In some embodiments, the valve is a solenoid valve. In some embodiments, the valve is a pinch valve. In some embodiments, the valve is a three-way solenoid pinch valve.

In some embodiments, the breast milk distribution system further includes a drive unit configured to open and close the valve. In some embodiments, the drive unit is a stepper motor or a linear actuator. In some embodiments, the stepper motor is attached to the manifold, wherein the stepper motor is configured to rotate the manifold. In some embodiments, the linear actuator is an electric linear actuator, a hydraulic linear actuator, or a pneumatic linear actuator.

In some embodiments, the breast milk distribution system further includes a fluid conduit providing fluidic communication between the breast cup and the inlet of the manifold. In some embodiments, the breast milk distribution system further includes a plurality of fluid conduits providing fluidic communication between each of the outlets of the manifold and the plurality of reservoirs.

In some embodiments, the plurality of reservoirs is disposed in an enclosure. In some embodiments, the enclosure includes a lid, e.g., wherein the manifold is disposed in the lid of the enclosure. In some embodiments, closure of the lid is configured to provide fluidic communication between at least one reservoir and at least one outlet of the manifold. In some embodiments, the enclosure further includes the pressure source. In some embodiments, the enclosure includes a cooling element and/or insulation. In some embodiments, the enclosure includes a weight sensor, e.g., a scale.

In some embodiments, the breast milk distribution system further includes a control unit configured to (i) send a signal to the valve to open and close or (ii) send a signal to the drive unit to move the moving, e.g., rotating, member.

The present invention provides a breast milk distribution system, including: a breast cup configured to receive a nipple; and a manifold in fluidic communication with the breast cup, wherein the manifold includes an inlet and an outlet that is configured to move from a first position to a second position.

In some embodiments, the breast milk distribution system further includes a plurality of reservoirs, wherein each of the plurality of reservoirs is configured to be in fluidic communication with the outlet of the manifold. In some embodiments, the outlet of the manifold is configured to be in fluidic communication with one reservoir at a time.

In some embodiments, each reservoir includes an inlet, and the inlet of the reservoir is configured to open and close. In some embodiments, each inlet of each reservoir includes a valve configured to open and close the inlet.

In some embodiments, each reservoir includes a pressure sensor.

In some embodiments, each reservoir includes a pressure outlet.

In some embodiments, the breast milk distribution system further includes a pressure source in fluidic communication with the breast cup, the manifold, and/or at least one of the plurality of reservoirs. In some embodiments, the pressure source is a negative pressure source or a positive pressure source.

In some embodiments, the breast cup includes (i) a housing; (ii) a breast shield; and (iii) a diaphragm disposed between the housing and the breast shield, wherein the diaphragm is further disposed between a pressure chamber and a milk chamber. In some embodiments, the negative pressure source is fluidic communication with the pressure chamber. In some embodiments, the plurality of reservoirs is configured to be in fluidic communication with the milk chamber.

In some embodiments, the breast milk distribution system further includes a drive unit configured to move the outlet. In some embodiments, the drive unit is a stepper motor or a linear actuator. In some embodiments, the manifold includes the stepper motor, and the stepper motor is configured to move, e.g., radially, the outlet of the manifold. In some embodiments, the linear actuator is an electric linear actuator, a hydraulic linear actuator, or a pneumatic linear actuator.

In some embodiments, the breast milk distribution system further includes a fluid conduit providing fluidic communication between the breast cup and the inlet of the manifold. In some embodiments, the breast milk distribution system further includes a fluid conduit providing fluidic communication between the inlet of the manifold and the outlet of the manifold.

In some embodiments, the breast milk distribution system further includes an arm, wherein the fluid conduit is disposed in and/or on the arm. In some embodiments, the arm includes an articulating arm.

In some embodiments, the plurality of reservoirs is disposed in an enclosure. In some embodiments, the enclosure includes a lid, and wherein the manifold is disposed in the lid of the enclosure.

In some embodiments, the breast milk distribution system further includes a hall effect sensor.

In some embodiments, the breast milk distribution system further includes a microswitch, e.g., to rehome the moving member.

The present invention provides a method of distributing milk from breast pumping, including: (i) providing the breast milk distribution system of the present disclosure; (ii) pumping a human breast to induce milk from a first breast pumping session to flow from a nipple to the manifold via a breast cup; (iii) providing fluidic communication between the inlet of the manifold and a first reservoir to allow milk from the first breast pumping session to flow into the first reservoir; (iv) removing fluidic communication between the inlet of the manifold and the first fluid reservoir; (v) pumping the human breast to induce milk from a second breast pumping session to flow from the nipple to the manifold via the breast cup; and (vi) providing fluidic communication between the inlet of the manifold and a second reservoir to allow milk from the second breast pumping session to flow into the second reservoir.

In some embodiments, providing fluidic communication between the inlet of the manifold and the first reservoir includes opening a first valve. In some embodiments, the control unit sends a signal to the first valve to open and/or close. In some embodiments, the control unit sends a signal to the second valve to open and/or close.

In some embodiments, the method further includes from 30 minutes to 240 minutes (about 30 minutes to 60 minutes, about 30 minutes to 90 minutes, about 60 minutes to about 180 minutes, about 60 minutes to about 120 minutes, about 90 minutes to 120 minutes, or about 120 minutes to 240 minutes) between step (ii) and step (v).

In some embodiments, the method further includes (vi) removing fluidic communication between the inlet of the manifold and the second fluid reservoir; (vii) providing fluidic communication between the inlet of the manifold and a third reservoir; and (viii) pumping the human breast to induce milk from a third breast pumping session to flow from the nipple to the manifold via the breast cup. In some embodiments, the method further includes from 30 minutes to 240 minutes (about 30 minutes to 60 minutes, about 30 minutes to 90 minutes, about 60 minutes to about 180 minutes, about 60 minutes to about 120 minutes, about 90 minutes to 120 minutes, or about 120 minutes to 240 minutes) between step (v) and step (viii).

In some embodiments, the method further includes providing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by moving, e.g., rotating, the moving, e.g., rotating, member. In some embodiments, the method further includes removing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by moving, e.g., rotating, the moving, e.g., rotating, member.

In some embodiments, the method further includes providing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by opening the valve to the inlet of the first reservoir, the second reservoir, or the third fluid reservoir. In some embodiments, the method further includes removing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by closing the valve to the inlet of the first reservoir, the second reservoir, or the third fluid reservoir.

In some embodiments, the method further includes providing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by moving the arm. In some embodiments, the method further includes removing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir, the second reservoir, or the third fluid reservoir by moving the arm. In some embodiments, the method further includes moving the arm with the drive unit, wherein the drive unit is the stepper motor.

In some embodiments, a subject including the human breast is moving, reclining, resting, or sleeping.

The present disclosure further provides a kit comprising a manifold and a plurality of reservoirs (e.g., 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 8, 2 to 10, 3 to 4, 3 to 5, 3 to 6, 4 to 5, 4 to 6, 4 to 8, 4 to 10, 5 to 10, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20).

Definitions

To facilitate the understanding of this invention, a number of terms are defined below and throughout the disclosure. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology herein is used to describe specific embodiments of the invention, but their usage does not limit the invention, except as outlined in the claims.

Terms such as “a”, “an,” and “the” are not intended to refer to only a singular entity but include the general class of which a specific example may be used for illustration.

The term “about,” as used herein, refers to a value that is within 10% above or below the value being described.

The term “fluidically connected,” as used herein, refers to a direct connection between at least two device elements, e.g., a channel, reservoir, etc., that allows for fluid to move between such device elements without passing through an intervening element.

The term “food contact substance,” as used herein, refers to a substance or material that is intended for use as a component in manufacturing, packing, packaging, transporting, or holding food in which such use is not intended to have any technical effect in such food.

The term “fluidic communication,” as used herein, refers to a connection between at least two device elements, e.g., a channel, reservoir, etc., that allows for fluid to move between such device elements with or without passing through one or more intervening device elements.

The term “valve,” as used herein, refers to an element which regulates, directs or controls the flow of a fluid by opening, closing, or partially obstructing a fluid pathway.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of the embodiments of the invention will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawing embodiments, which are presently exemplified. It should be understood, however, that the invention is not limited to the precise arrangement and instrumentalities of the embodiments shown in the drawings.

FIG. 1 shows a schematic drawing of a breast pump system (1), including a pump housing (7), a power switch (14), two breast cups (2), and two fluid conduits (5).

FIG. 2A and FIG. 2B show schematic drawings of a breast pump system, including a pump housing (7), a power switch (14), two breast cups (2), and two fluid conduits (5).

FIG. 3A-3E show schematic drawings of a pump housing (7).

FIG. 4A and FIG. 4B show schematic drawings of a pump housing releasably secured with a plurality of fasteners.

FIG. 5A-5D show schematic drawings of a pump housing including a negative pressure source, a positive pressure source, a control valve, and a drive unit.

FIG. 6A and FIG. 6B show schematic drawings of a pump housing including a negative pressure source, a positive pressure source, a control valve, and a drive unit.

FIG. 7A and FIG. 7B show schematic drawings of a pump housing, including a negative pressure source (9), a positive pressure source, a control valve (10), a drive unit (11), two power sources (12), and a power switch (14).

FIG. 8A, FIG. 8B, and FIG. 8C show schematic drawings of a pump housing (7), including a negative pressure source (9), a positive pressure source, a control valve (10), a drive unit (11), two power sources (12 and 16), and a power switch (14).

FIG. 9A-9D show schematics of a pump housing.

FIG. 10 shows a schematic drawing of a pump housing including a negative pressure source (9), a positive pressure source, a control valve (10), a drive unit (11), and a power switch (14).

FIG. 11 shows a schematic drawing of a cover of a pump housing.

FIG. 12 shows a schematic drawing of a base of a pump housing.

FIG. 13 shows a schematic drawing of a body of a pump housing (7).

FIG. 14 shows a schematic of a breast cup (2) including a wide portion (8) and a nipple tunnel (13).

FIG. 15 shows a reservoir enclosure (4) including a reservoir (3) containing milk and a one directional valve (15).

FIG. 16A and FIG. 16B show schematic drawings of a breast pump system of the disclosure.

FIG. 17 shows a schematic drawing of breast cup (2), including housing (17), diaphragm (18), breast shield (19), pressure chamber (20), milk chamber (21), outlet (22), and sealing point (23).

FIG. 18 shows a schematic drawing of breast cup (2), including housing (17), diaphragm (18), breast shield (19), pressure chamber (20), milk chamber (21), outlet (22), and valve (24).

FIG. 19 shows a schematic drawing of breast cup (2), including housing (17), diaphragm (18), breast shield (19), pressure chamber (20), milk chamber (21), outlet (22), sealing point (23), and orifices (25).

FIG. 20 shows a schematic drawing of breast cup (2), including housing (17), diaphragm (18), breast shield (19), pressure chamber (20), milk chamber (21), outlet (22), sealing point (23), and milk chamber wall (26).

FIG. 21A and FIG. 21B show schematic drawings of breast shield (19) having a protrusion (27) on the inner surface of breast shield (19), wherein the inner surface of breast shield (19) is configured to contact the breast of a user. FIG. 21A shows a schematic drawing of breast shield (19) having a toroidal ridge on the inner surface of breast shield (19). FIG. 21 B shows a schematic drawing of breast shield (19) having a curved toroidal ridge on the inner surface of breast shield (19).

FIG. 22 shows a schematic drawing of a milk distribution system (28) including (i) a plurality of reservoirs (3) and (ii) a manifold (29) having an inlet (30), at least one outlet (31), and an integral drive unit (11), wherein the manifold (29) is configured to rotate to provide fluidic communication between an outlet of the manifold (31) and a reservoir (3).

FIG. 23 shows a schematic drawing of a milk distribution system (28) including (i) a plurality of reservoirs (3), (ii) a drive unit (11), and (iii) a manifold (29) having an inlet (30) and at least one outlet (31), wherein the drive unit (11) is configured to rotate the manifold (29) to provide fluidic communication between an outlet of the manifold (31) and a reservoir (3).

FIG. 24 shows a schematic drawing of a milk distribution system (28) including (i) a plurality of reservoirs (3) and (ii) a manifold (29) having an inlet (30) and at least out outlet (31), wherein each of the reservoirs (3) includes a valve (24), in particular, a solenoid valve, wherein the solenoid valve is configured to provide fluidic communication between an outlet of the manifold (31) and a reservoir (3).

FIG. 25 shows a schematic drawing of a milk distribution system (28) including (i) a plurality of reservoirs (3), (ii) a pressure source (32), (iii) and a manifold (29) having an inlet (30) and at least one outlet (31), wherein the pressure source (32) is configured to provide fluidic communication between an outlet of the manifold (31) and a reservoir (3).

FIG. 26A-26D show views of a breast cup (2) including housing (17), diaphragm (18), breast shield (19), pressure chamber (20), milk chamber (21), milk chamber wall (26), ports, and a one directional valve (15).

FIGS. 27A-27B show a milk distribution system including a manifold with four arms, an inlet (30), outlet (31), alignment plate (33), weighing plate (34), vertical body (35), gasket (36), drive dog (37), stationary base (38), and a stepper motor (39).

FIG. 28 shows a schematic of a milk distribution system (28) with a flush line and negative pressure source.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure provides improved breast pump systems, components thereof, e.g., breast cups, and methods of use thereof. The present breast pump systems are particularly advantageous for navigating daily activities, resting, reclining, or sleeping.

The present disclosure further provides improved milk distribution systems and methods of use thereof. The present milk distribution systems are particularly advantageous for use in a series of breast pumping sessions without removal of a breast cup and/or without replacement of a reservoir in the breast pump system.

Breast Pump System

The present disclosure provides an improved breast pump system. The breast pump system (1) is advantageous in that it comfortably allows for pumping in any position, such as lying reclined, flat, or on the side; allows for pumping without assembly at the time of use; allows for a plurality of breast pumping sessions without the removal of the breast cup (2); decreases the likelihood of waking up a partner while breast pumping; and/or allows for the collection and storage of milk for extended periods of time, e.g., while the mother rests or sleeps. Exemplary systems are shown in FIGS. 16A-16B.

The breast pump system (1) may include at least one breast cup (2) in fluidic communication with a pressure source (9) and a reservoir (3). FIG. 1 shows a breast pump system (1), including a pump housing (7), a power switch (14), two breast cups (2), and two fluid conduits (5). FIG. 2A and FIG. 2B show a breast pump system (1), including two breast cups (2), a first fluid conduit (5), a second fluid conduit (5), and a pump housing (7) having a power switch (14). The first fluid conduit (5) and second fluid conduit (5) provide fluidic communication between the breast cup (2), the pressure source (9) disposed in the pump housing (7), and at least one reservoir (3) disposed in the reservoir enclosure (4).

As shown in, e.g., FIG. 17 , the breast pump system (1) can include a breast cup (2) having a housing (17), a breast shield (19), and a diaphragm (18) disposed between the housing (17) and the breast shield (19). The diaphragm (18) can separate the pressure chamber (20) from the milk chamber (21). The diaphragm provides numerous advantages including improved breast pumping in reclined positions. A negative pressure source (9) and/or a positive pressure source can be in fluidic communication with the pressure chamber (20), and the reservoir (3) can be in fluidic communication with the milk chamber (21).

The breast pump system (1) can include a food contact substance, e.g., for surfaces that contact milk and the breast. Alternatively, or in addition, the breast pump system (1) can include an infant grade material.

The breast pump system (1), including any element therein, can include a polymer (e.g., polyvinyl chloride (PVC), polyethylene terephthalate (PET), polypropylene (PP), polytetrafluoroethylene (PTFE), polyethylene, high-density polyethylene (HDPE), low-density polyethylene (LDPE), copolyester (e.g., Tritan EX401), polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, nylon, polyvinylidene fluoride (PVDF), silicone, or polycarbonate (PC)). For example, the reservoir (3), the reservoir enclosure (4), the fluid conduit (5), or the breast cup (2), including the housing (17), breast shield (19), and diaphragm (18) can include a polymer.

In some embodiments, breast pump system (1) can include a fabric (e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill). For example, the reservoir (3), the reservoir enclosure (4), or the breast cup (2), including the housing (17) and the breast shield (19), can include a fabric.

In some embodiments, the breast pump system (1) includes a foam, e.g., an open cell foam. For example, the reservoir (3), the reservoir enclosure (4), or the breast cup (2), including the housing (17) and the breast shield (19), can include a foam.

Pump Housing

The pump housing (7), the exterior of which is shown in, e.g., FIGS. 3A-3E, may include various components, e.g., as shown in FIGS. 5A-5D, including a negative pressure source (9), a positive pressure source, a control valve (10), a drive unit (11), and/or a power source (12). In some embodiments, such as that shown in FIG. 7A and FIG. 7B, the pump housing (7) includes a second power source (16).

The pump housing (7) may include a cover (FIG. 11 ), a base (FIG. 12 ), and a body (FIG. 13 ). FIG. 6A and FIG. 6B show a pump housing (7) without a housing body, the components releasably or non-releasably secured to the housing base. FIG. 11 , FIG. 12 , and FIG. 13 show that the cover, base, and body of the pump housing may be snap-fit together. The pump housing (7) may be releasably secured with at least one fastener, e.g., as shown in FIG. 4A and FIG. 4B.

The pump housing (7) may include any polymer (e.g., PVC, PET, PP, PTFE, polyethylene, HDPE, LDPE, copolyester (e.g., Tritan EX401), polystyrene, a thermoplastic elastomer, a thermoplastic polyurethane, nylon, PVDF, or PC) or other suitable material, e.g., metal or ceramic. The pump housing (7) may be injection molded. In some embodiments, the pump housing includes a reservoir enclosure (4) disposed therein.

Pressure Source

The breast pump system (1) and/or the milk distribution system (28) can include a pressure source, e.g., a negative pressure source (9) and/or a positive pressure source. Specifically, the pressure source is configured to be used to move fluids, such as air, water, milk, and/or cleaning fluid, in the breast pump system (1) and/or the milk distribution system (28). In some embodiments, the breast pump system (1) and/or the milk distribution system (28) includes a plurality of pressure sources (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10). In some embodiments, at least one pressure source is a peristaltic pump. In some embodiments, at least one pressure source is a vacuum pump, e.g., which is capable of producing negative and positive pressure.

In some embodiments, the breast pump system (1) includes a negative pressure source (9) that provides negative pressure to the breast cup (2), and thus the nipple of the breast in order to express milk. Additionally, the negative pressure source (9) may be configured transport milk in the breast pump system (1), e.g., to expand and/or compress the pressure chamber (20) and/or the milk chamber (21). In some embodiments, the negative pressure source (9) is a vacuum pump.

In some embodiments, the breast pump system (1) includes a positive pressure source that provides positive pressure to the breast cup (2) to aid in transportation of milk in the breast pump system, e.g., to expand and/or compress the pressure chamber (20) and/or the milk chamber (21). In some embodiments, the positive pressure source is a pressure pump, a manually compressible chamber, a vacuum pump, a peristaltic pump, or a valve to the ambient atmosphere.

In some embodiments, pressure applied to the breast cup (2) varies. In some embodiments, the pressure source applies pressure to the breast cup (2) for 1 to 20 cycles (e.g., 1 to 2 cycles, 1 to 3 cycles, 1 to 4 cycles, 1 to 5 cycles, 1 to 6 cycles, 1 to 7 cycles, 1 to 8 cycles, 1 to 9 cycles, 1 to 10 cycles, 1 to 15 cycles, 2 to 3 cycles, 2 to 4 cycles, 2 to 5 cycles, 3 to 7 cycles, 4 to 6 cycles, 5 to 10 cycles, 5 to 15 cycles, 10 to 15 cycles, 15 to 20 cycles, 1 cycle, 2 cycles, 3 cycles, 4 cycles, 5 cycles, 6 cycles, 7 cycles, 8 cycles, 9 cycles, 10 cycles, 11 cycles, 12 cycles, 13 cycles, 14 cycles, 15 cycles, 16 cycles, 17 cycles, 18 cycles, 19 cycles, or 20 cycles). A first cycle may apply a maximum negative pressure of 0 mmHg to about 400 mmHg and/or a maximum positive pressure of about 0 mmHg to about 400 mmHg of positive pressure. A second cycle may apply a maximum negative pressure of about 0 mmHg to about 400 mmHg and/or a maximum positive pressure of about 0 mmHg to about 400 mmHg of positive pressure. Likewise, a third, fourth, fifth, etc., cycle, may apply a maximum negative pressure of about 0 mmHg to about 400 mmHg and/or a maximum positive pressure of about 0 mmHg to about 400 mmHg of positive pressure.

In some embodiments, the milk distribution system (28) includes a pressure source in fluidic communication with the breast cup (2), the manifold (29), and/or at least one of the plurality of reservoirs (3). In some embodiments, the milk distribution system (28) includes a pressure source configured to transport milk from the breast cup (2) to a reservoir (3). In some embodiments, this pressure source is the same pressure source used to pressurize the pressure chamber (20). In some embodiments, this pressure source is a different pressure source than is used to pressurize the pressure chamber (20). In some embodiments, this pressure source is a peristaltic pump. In some embodiments, milk distribution system (28) includes a fluid conduit (5) in fluidic communication with the breast cup (2), the manifold (29), at least one reservoir (3), and/or another fluid conduit (5) providing fluidic communication between components of the milk distribution system (28). In some embodiments, the pressure source is a negative pressure source (9) or a positive pressure source. In some embodiments, the pressure source is configured to open and/close an outlet of the manifold (31). In some embodiments, the pressure source is configured to open and/close an inlet of a reservoir, e.g., as shown in FIG. 25 . In some embodiments, the inlet of a reservoir (3) is nominally closed and is configured to open upon pressurization provided by a pressure source.

The negative pressure source (9) may provide a negative pressure from about 0 mmHg to about 400 mmHg (e.g., about 0 mmHg to about 10 mmHg, about 0 mmHg to about 20 mmHg, about 0 mmHg to about 30 mmHg, about 0 mmHg to about 40 mmHg, about 0 mmHg to about 50 mmHg, about 0 mmHg to about 60 mmHg, about 0 mmHg to about 70 mmHg, about 0 mmHg to about 80 mmHg, about 0 mmHg to about 90 mmHg, about 0 to about 100 mmHg, about 0 mmHg to about 110 mmHg, about 0 mmHg to about 120 mmHg, about 0 mmHg to about 130 mmHg, about 0 to about 140 mmHg, about 0 mmHg to about 150 mmHg, about 0 to about 175 mmHg, about 0 mmHg to about 200 mmHg, about 0 mmHg to about 225 mmHg, about 0 mmHg to about 250 mmHg, about 0 mmHg to about 275 mmHg, about 0 mmHg to about 300 mmHg, about 0 to about 350 mmHg, about 0 mmHg to about 400 mmHg, about 10 mmHg to about 20 mmHg, about 10 mmHg to about 30 mmHg, about 10 mmHg to about 40 mmHg, about 10 mmHg to about 50 mmHg, about 10 mmHg to about 60 mmHg, about 10 mmHg to about 70 mmHg, about 10 mmHg to about 80 mmHg, about 10 mmHg to about 90 mmHg, about 10 mmHg to about 100 mmHg, about 10 mmHg to about 110 mmHg, about 10 mmHg to about 120 mmHg, about 10 mmHg to about 130 mmHg, about 10 mmHg to about 140 mmHg, about 10 mmHg to about 150 mmHg, about 10 mmHg to about 175 mmHg, about 10 mmHg to about 200 mmHg, about 10 mmHg to about 225 mmHg, about 10 mmHg to about 250 mmHg, about 10 mmHg to about 300 mmHg, about 10 to about 350 mmHg, about 10 mmHg to about 400 mmHg, about 20 mmHg to about 30 mmHg, about 20 mmHg to about 40 mmHg, about 20 mmHg to about 50 mmHg, about 20 mmHg to about 60 mmHg, about 20 mmHg to about 70 mmHg, about 20 mmHg to about 80 mmHg, about 20 mmHg to about 90 mmHg, about 20 mmHg to about 100 mmHg, about 20 mmHg to about 110 mmHg, about 20 mmHg to about 120 mmHg, about 20 mmHg to about 130 mmHg, about 20 mmHg to about 140 mmHg, about 20 mmHg to about 150 mmHg, about 20 mmHg to about 175 mmHg, about 20 mmHg to about 200 mmHg, about 20 mmHg to about 225 mmHg, about 20 mmHg to about 250 mmHg, about 20 mmHg to about 300 mmHg, about 20 to about 350 mmHg, about 20 mmHg to about 400 mmHg, about 25 mmHg to about 50 mmHg, about 25 mmHg to about 75 mmHg, about 25 mmHg to about 100 mmHg, about 30 mmHg to about 40 mmHg, about 30 mmHg to about 50 mmHg, about 30 mmHg to about 60 mmHg, about 30 mmHg to about 70 mmHg, about 30 mmHg to about 80 mmHg, about 30 mmHg to about 90 mmHg, about 30 mmHg to about 100 mmHg, about 30 mmHg to about 110 mmHg, about 30 mmHg to about 120 mmHg, about 30 mmHg to about 130 mmHg, about 30 mmHg to about 140 mmHg, about 30 mmHg to about 150 mmHg, about 30 mmHg to about 175 mmHg, about 30 mmHg to about 200 mmHg, about 30 mmHg to about 225 mmHg, about 30 mmHg to about 250 mmHg, about 30 mmHg to about 300 mmHg, about 30 to about 350 mmHg, about 30 mmHg to about 400 mmHg, about 40 mmHg to about 50 mmHg, about 40 mmHg to about 60 mmHg, about 40 mmHg to about 70 mmHg, about 40 mmHg to about 80 mmHg, about 40 mmHg to about 90 mmHg, about 40 mmHg to about 100 mmHg, about 40 mmHg to about 110 mmHg, about 40 mmHg to about 120 mmHg, about 40 mmHg to about 130 mmHg, about 40 mmHg to about 140 mmHg, about 40 mmHg to about 150 mmHg, about 40 mmHg to about 175 mmHg, about 40 mmHg to about 200 mmHg, about 40 mmHg to about 225 mmHg, about 40 mmHg to about 250 mmHg, about 40 mmHg to about 300 mmHg, about 40 to about 350 mmHg, about 40 mmHg to about 400 mmHg, about 50 mmHg to about 60 mmHg, about 50 mmHg to about 70 mmHg, about 50 mmHg to about 75 mmHg, about 50 mmHg to about 80 mmHg, about 50 mmHg to about 90 mmHg, about 50 mmHg to about 100 mmHg, about 50 mmHg to about 110 mmHg, about 50 mmHg to about 120 mmHg, about 50 mmHg to about 130 mmHg, about mmHg 50 to about 140 mmHg, about 50 mmHg to about 150 mmHg, about 50 mmHg to about 175 mmHg, about 50 mmHg to about 200 mmHg, about 50 mmHg to about 225 mmHg, about 50 mmHg to about 250 mmHg, about 50 mmHg to about 300 mmHg, about 50 to about 350 mmHg, about 50 mmHg to about 400 mmHg, about 60 mmHg to about 70 mmHg, about 60 mmHg to about 80 mmHg, about 60 mmHg to about 90 mmHg, about 60 mmHg to about 100 mmHg, about 60 mmHg to about 110 mmHg, about 60 mmHg to about 120 mmHg, about 60 mmHg to about 130 mmHg, about 60 mmHg to about 140 mmHg, about 60 mmHg to about 150 mmHg, about 60 mmHg to about 175 mmHg, about 60 mmHg to about 200 mmHg, about 60 mmHg to about 225 mmHg, about 60 mmHg to about 250 mmHg, about 60 mmHg to about 300 mmHg, about 60 to about 350 mmHg, about 60 mmHg to about 400 mmHg, about 70 mmHg to about 80 mmHg, about 70 mmHg to about 90 mmHg, about 70 mmHg to about 100 mmHg, about 70 mmHg to about 110 mmHg, about 70 mmHg to about 120 mmHg, about 70 mmHg to about 130 mmHg, about 70 mmHg to about 140 mmHg, about 70 mmHg to about 150 mmHg, about 70 mmHg to about 175 mmHg, about 70 mmHg to about 200 mmHg, about 70 mmHg to about 225 mmHg, about 70 mmHg to about 250 mmHg, about 70 mmHg to about 300 mmHg, about 70 to about 350 mmHg, about 70 mmHg to about 400 mmHg, about 75 mmHg to about 100 mmHg, about 75 mmHg to about 125 mmHg, about 80 mmHg to about 90 mmHg, about 80 mmHg to about 100 mmHg, about 80 mmHg to about 110 mmHg, about 80 mmHg to about 120 mmHg, about 80 mmHg to about 130 mmHg, about 80 mmHg to about 140 mmHg, about 80 mmHg to about 150 mmHg, about 80 mmHg to about 175 mmHg, about 80 mmHg to about 200 mmHg, about 80 mmHg to about 225 mmHg, about 80 mmHg to about 250 mmHg, about 80 mmHg to about 300 mmHg, about 80 to about 350 mmHg, about 80 mmHg to about 400 mmHg, about 90 mmHg to about 100 mmHg, about 90 mmHg to about 110 mmHg, about 90 mmHg to about 120 mmHg, about 90 mmHg to about 130 mmHg, about 90 mmHg to about 140 mmHg, about 90 mmHg to about 150 mmHg, about 90 mmHg to about 175 mmHg, about 90 mmHg to about 200 mmHg, about 90 mmHg to about 225 mmHg, about 90 mmHg to about 250 mmHg, about 90 mmHg to about 300 mmHg, about 90 to about 350 mmHg, about 90 mmHg to about 400 mmHg, about 100 mmHg to about 110 mmHg, about 100 mmHg to about 120 mmHg, about 100 mmHg to about 130 mmHg, about 100 mmHg to about 140 mmHg, about 100 mmHg to about 150 mmHg, about 100 mmHg to about 175 mmHg, about 100 mmHg to about 200 mmHg, about 100 mmHg to about 225 mmHg, about 100 mmHg to about 250 mmHg, about 100 mmHg to about 300 mmHg, about 100 to about 350 mmHg, about 100 mmHg to about 400 mmHg, about 110 mmHg to about 120 mmHg, about 110 mmHg to about 130 mmHg, about 110 mmHg to about 140 mmHg, about 110 mmHg to about 150 mmHg, about 110 mmHg to about 175 mmHg, about 110 mmHg to about 200 mmHg, about 110 mmHg to about 225 mmHg, about 110 mmHg to about 250 mmHg, about 110 mmHg to about 300 mmHg, about 110 to about 350 mmHg, about 110 mmHg to about 400 mmHg, about 120 mmHg to about 130 mmHg, about 120 mmHg to about 140 mmHg, about 120 mmHg to about 150 mmHg, about 120 mmHg to about 175 mmHg, about 120 mmHg to about 200 mmHg, about 120 mmHg to about 225 mmHg, about 120 mmHg to about 250 mmHg, about 120 mmHg to about 300 mmHg, about 120 to about 350 mmHg, about 120 mmHg to about 400 mmHg, about 130 mmHg to about 140 mmHg, about 130 mmHg to about 150 mmHg, about 130 mmHg to about 175 mmHg, about 130 mmHg to about 200 mmHg, about 130 mmHg to about 225 mmHg, about 130 mmHg to about 250 mmHg, about 130 mmHg to about 300 mmHg, about 130 to about 350 mmHg, about 130 mmHg to about 400 mmHg, about 140 mmHg to about 150 mmHg, about 140 mmHg to about 175 mmHg, about 140 mmHg to about 200 mmHg, about 140 mmHg to about 225 mmHg, about 140 mmHg to about 250 mmHg, about 140 mmHg to about 300 mmHg, about 140 to about 350 mmHg, about 140 mmHg to about 400 mmHg, about 150 mmHg to about 175 mmHg, about 150 mmHg to about 200 mmHg, about 150 mmHg to about 225 mmHg, about 150 mmHg to about 250 mmHg, about 150 mmHg to about 300 mmHg, about 150 to about 350 mmHg, about 150 mmHg to about 400 mmHg, about 175 mmHg to about 200 mmHg, about 175 mmHg to about 225 mmHg, about 175 mmHg to about 250 mmHg, about 175 mmHg to about 300 mmHg, about 175 to about 350 mmHg, about 175 mmHg to about 400 mmHg, about 200 mmHg to about 225 mmHg, about 200 mmHg to about 250 mmHg, about 200 mmHg to about 300 mmHg, about 200 to about 350 mmHg, about 200 mmHg to about 400 mmHg, about 225 mmHg to about 250 mmHg, about 225 mmHg to about 300 mmHg, about 225 to about 350 mmHg, about 225 mmHg to about 400 mmHg, about 275 mmHg to about 300 mmHg, about 275 to about 350 mmHg, about 275 mmHg to about 400 mmHg, about 300 mmHg to about 325 mmHg, about 300 to about 350 mmHg, about 300 mmHg to about 400 mmHg, about 325 mmHg to about 350 mmHg, about 325 to about 375 mmHg, about 325 mmHg to about 400 mmHg, about 350 mmHg to about 375 mmHg, about 350 to about 400 mmHg, or about 375 mmHg to about 400 mmHg.

The positive pressure source can provide a positive pressure from about 0 mmHg to about 400 mmHg (e.g., about 0 mmHg to about 10 mmHg, about 0 mmHg to about 20 mmHg, about 0 mmHg to about 30 mmHg, about 0 mmHg to about 40 mmHg, about 0 mmHg to about 50 mmHg, about 0 mmHg to about 60 mmHg, about 0 mmHg to about 70 mmHg, about 0 mmHg to about 80 mmHg, about 0 mmHg to about 90 mmHg, about 0 to about 100 mmHg, about 0 mmHg to about 110 mmHg, about 0 mmHg to about 120 mmHg, about 0 mmHg to about 130 mmHg, about 0 to about 140 mmHg, about 0 mmHg to about 150 mmHg, about 0 to about 175 mmHg, about 0 mmHg to about 200 mmHg, about 0 mmHg to about 225 mmHg, about 0 mmHg to about 250 mmHg, about 0 mmHg to about 275 mmHg, about 0 mmHg to about 300 mmHg, about 0 to about 350 mmHg, about 0 mmHg to about 400 mmHg, about 10 mmHg to about 20 mmHg, about 10 mmHg to about 30 mmHg, about 10 mmHg to about 40 mmHg, about 10 mmHg to about 50 mmHg, about 10 mmHg to about 60 mmHg, about 10 mmHg to about 70 mmHg, about 10 mmHg to about 80 mmHg, about 10 mmHg to about 90 mmHg, about 10 mmHg to about 100 mmHg, about 10 mmHg to about 110 mmHg, about 10 mmHg to about 120 mmHg, about 10 mmHg to about 130 mmHg, about 10 mmHg to about 140 mmHg, about 10 mmHg to about 150 mmHg, about 10 mmHg to about 175 mmHg, about 10 mmHg to about 200 mmHg, about 10 mmHg to about 225 mmHg, about 10 mmHg to about 250 mmHg, about 10 mmHg to about 300 mmHg, about 10 to about 350 mmHg, about 10 mmHg to about 400 mmHg, about 20 mmHg to about 30 mmHg, about 20 mmHg to about 40 mmHg, about 20 mmHg to about 50 mmHg, about 20 mmHg to about 60 mmHg, about 20 mmHg to about 70 mmHg, about 20 mmHg to about 80 mmHg, about 20 mmHg to about 90 mmHg, about 20 mmHg to about 100 mmHg, about 20 mmHg to about 110 mmHg, about 20 mmHg to about 120 mmHg, about 20 mmHg to about 130 mmHg, about 20 mmHg to about 140 mmHg, about 20 mmHg to about 150 mmHg, about 20 mmHg to about 175 mmHg, about 20 mmHg to about 200 mmHg, about 20 mmHg to about 225 mmHg, about 20 mmHg to about 250 mmHg, about 20 mmHg to about 300 mmHg, about 20 to about 350 mmHg, about 20 mmHg to about 400 mmHg, about 25 mmHg to about 50 mmHg, about 25 mmHg to about 75 mmHg, about 25 mmHg to about 100 mmHg, about 30 mmHg to about 40 mmHg, about 30 mmHg to about 50 mmHg, about 30 mmHg to about 60 mmHg, about 30 mmHg to about 70 mmHg, about 30 mmHg to about 80 mmHg, about 30 mmHg to about 90 mmHg, about 30 mmHg to about 100 mmHg, about 30 mmHg to about 110 mmHg, about 30 mmHg to about 120 mmHg, about 30 mmHg to about 130 mmHg, about 30 mmHg to about 140 mmHg, about 30 mmHg to about 150 mmHg, about 30 mmHg to about 175 mmHg, about 30 mmHg to about 200 mmHg, about 30 mmHg to about 225 mmHg, about 30 mmHg to about 250 mmHg, about 30 mmHg to about 300 mmHg, about 30 to about 350 mmHg, about 30 mmHg to about 400 mmHg, about 40 mmHg to about 50 mmHg, about 40 mmHg to about 60 mmHg, about 40 mmHg to about 70 mmHg, about 40 mmHg to about 80 mmHg, about 40 mmHg to about 90 mmHg, about 40 mmHg to about 100 mmHg, about 40 mmHg to about 110 mmHg, about 40 mmHg to about 120 mmHg, about 40 mmHg to about 130 mmHg, about 40 mmHg to about 140 mmHg, about 40 mmHg to about 150 mmHg, about 40 mmHg to about 175 mmHg, about 40 mmHg to about 200 mmHg, about 40 mmHg to about 225 mmHg, about 40 mmHg to about 250 mmHg, about 40 mmHg to about 300 mmHg, about 40 to about 350 mmHg, about 40 mmHg to about 400 mmHg, about 50 mmHg to about 60 mmHg, about 50 mmHg to about 70 mmHg, about 50 mmHg to about 75 mmHg, about 50 mmHg to about 80 mmHg, about 50 mmHg to about 90 mmHg, about 50 mmHg to about 100 mmHg, about 50 mmHg to about 110 mmHg, about 50 mmHg to about 120 mmHg, about 50 mmHg to about 130 mmHg, about mmHg 50 to about 140 mmHg, about 50 mmHg to about 150 mmHg, about 50 mmHg to about 175 mmHg, about 50 mmHg to about 200 mmHg, about 50 mmHg to about 225 mmHg, about 50 mmHg to about 250 mmHg, about 50 mmHg to about 300 mmHg, about 50 to about 350 mmHg, about 50 mmHg to about 400 mmHg, about 60 mmHg to about 70 mmHg, about 60 mmHg to about 80 mmHg, about 60 mmHg to about 90 mmHg, about 60 mmHg to about 100 mmHg, about 60 mmHg to about 110 mmHg, about 60 mmHg to about 120 mmHg, about 60 mmHg to about 130 mmHg, about 60 mmHg to about 140 mmHg, about 60 mmHg to about 150 mmHg, about 60 mmHg to about 175 mmHg, about 60 mmHg to about 200 mmHg, about 60 mmHg to about 225 mmHg, about 60 mmHg to about 250 mmHg, about 60 mmHg to about 300 mmHg, about 60 to about 350 mmHg, about 60 mmHg to about 400 mmHg, about 70 mmHg to about 80 mmHg, about 70 mmHg to about 90 mmHg, about 70 mmHg to about 100 mmHg, about 70 mmHg to about 110 mmHg, about 70 mmHg to about 120 mmHg, about 70 mmHg to about 130 mmHg, about 70 mmHg to about 140 mmHg, about 70 mmHg to about 150 mmHg, about 70 mmHg to about 175 mmHg, about 70 mmHg to about 200 mmHg, about 70 mmHg to about 225 mmHg, about 70 mmHg to about 250 mmHg, about 70 mmHg to about 300 mmHg, about 70 to about 350 mmHg, about 70 mmHg to about 400 mmHg, about 75 mmHg to about 100 mmHg, about 75 mmHg to about 125 mmHg, about 80 mmHg to about 90 mmHg, about 80 mmHg to about 100 mmHg, about 80 mmHg to about 110 mmHg, about 80 mmHg to about 120 mmHg, about 80 mmHg to about 130 mmHg, about 80 mmHg to about 140 mmHg, about 80 mmHg to about 150 mmHg, about 80 mmHg to about 175 mmHg, about 80 mmHg to about 200 mmHg, about 80 mmHg to about 225 mmHg, about 80 mmHg to about 250 mmHg, about 80 mmHg to about 300 mmHg, about 80 to about 350 mmHg, about 80 mmHg to about 400 mmHg, about 90 mmHg to about 100 mmHg, about 90 mmHg to about 110 mmHg, about 90 mmHg to about 120 mmHg, about 90 mmHg to about 130 mmHg, about 90 mmHg to about 140 mmHg, about 90 mmHg to about 150 mmHg, about 90 mmHg to about 175 mmHg, about 90 mmHg to about 200 mmHg, about 90 mmHg to about 225 mmHg, about 90 mmHg to about 250 mmHg, about 90 mmHg to about 300 mmHg, about 90 to about 350 mmHg, about 90 mmHg to about 400 mmHg, about 100 mmHg to about 110 mmHg, about 100 mmHg to about 120 mmHg, about 100 mmHg to about 130 mmHg, about 100 mmHg to about 140 mmHg, about 100 mmHg to about 150 mmHg, about 100 mmHg to about 175 mmHg, about 100 mmHg to about 200 mmHg, about 100 mmHg to about 225 mmHg, about 100 mmHg to about 250 mmHg, about 100 mmHg to about 300 mmHg, about 100 to about 350 mmHg, about 100 mmHg to about 400 mmHg, about 110 mmHg to about 120 mmHg, about 110 mmHg to about 130 mmHg, about 110 mmHg to about 140 mmHg, about 110 mmHg to about 150 mmHg, about 110 mmHg to about 175 mmHg, about 110 mmHg to about 200 mmHg, about 110 mmHg to about 225 mmHg, about 110 mmHg to about 250 mmHg, about 110 mmHg to about 300 mmHg, about 110 to about 350 mmHg, about 110 mmHg to about 400 mmHg, about 120 mmHg to about 130 mmHg, about 120 mmHg to about 140 mmHg, about 120 mmHg to about 150 mmHg, about 120 mmHg to about 175 mmHg, about 120 mmHg to about 200 mmHg, about 120 mmHg to about 225 mmHg, about 120 mmHg to about 250 mmHg, about 120 mmHg to about 300 mmHg, about 120 to about 350 mmHg, about 120 mmHg to about 400 mmHg, about 130 mmHg to about 140 mmHg, about 130 mmHg to about 150 mmHg, about 130 mmHg to about 175 mmHg, about 130 mmHg to about 200 mmHg, about 130 mmHg to about 225 mmHg, about 130 mmHg to about 250 mmHg, about 130 mmHg to about 300 mmHg, about 130 to about 350 mmHg, about 130 mmHg to about 400 mmHg, about 140 mmHg to about 150 mmHg, about 140 mmHg to about 175 mmHg, about 140 mmHg to about 200 mmHg, about 140 mmHg to about 225 mmHg, about 140 mmHg to about 250 mmHg, about 140 mmHg to about 300 mmHg, about 140 to about 350 mmHg, about 140 mmHg to about 400 mmHg, about 150 mmHg to about 175 mmHg, about 150 mmHg to about 200 mmHg, about 150 mmHg to about 225 mmHg, about 150 mmHg to about 250 mmHg, about 150 mmHg to about 300 mmHg, about 150 to about 350 mmHg, about 150 mmHg to about 400 mmHg, about 175 mmHg to about 200 mmHg, about 175 mmHg to about 225 mmHg, about 175 mmHg to about 250 mmHg, about 175 mmHg to about 300 mmHg, about 175 to about 350 mmHg, about 175 mmHg to about 400 mmHg, about 200 mmHg to about 225 mmHg, about 200 mmHg to about 250 mmHg, about 200 mmHg to about 300 mmHg, about 200 to about 350 mmHg, about 200 mmHg to about 400 mmHg, about 225 mmHg to about 250 mmHg, about 225 mmHg to about 300 mmHg, about 225 to about 350 mmHg, about 225 mmHg to about 400 mmHg, about 275 mmHg to about 300 mmHg, about 275 to about 350 mmHg, about 275 mmHg to about 400 mmHg, about 300 mmHg to about 325 mmHg, about 300 to about 350 mmHg, about 300 mmHg to about 400 mmHg, about 325 mmHg to about 350 mmHg, about 325 to about 375 mmHg, about 325 mmHg to about 400 mmHg, about 350 mmHg to about 375 mmHg, about 350 to about 400 mmHg, or about 375 mmHg to about 400 mmHg.

In some embodiments, pressure applied to the breast cup (2) may change, e.g., from about every 0.1 seconds to about every 120 seconds (e.g., about every 0.1 seconds to about every 1 second, about every 0.1 seconds to about every 2 seconds, about every 0.1 seconds to about every 3 seconds, about every 0.1 seconds to about every 4 seconds, about every 0.1 seconds to about every 5 seconds, about every 0.1 seconds to about every 6 seconds, about every 0.1 seconds to about every 7 seconds, about every 0.1 seconds to about every 8 seconds, about every 0.1 seconds to about every 9 seconds, about every 0.1 seconds to about every 10 seconds, about every 0.1 seconds to about every 11 seconds, about every 0.1 seconds to about every 12 seconds, about every 0.1 seconds to about every 13 seconds, about every 0.1 seconds to about every 14 seconds, about every 0.1 seconds to about every 15 seconds, about every 0.1 seconds to about every 20 seconds, about every 0.1 seconds to about every 30 seconds, about every 0.1 seconds to about every 45 seconds, about every 0.1 seconds to about every 60 seconds, about every 0.1 seconds to about every 90 seconds, about every 1 second to about every 2 seconds, about every 1 second to about every 3 seconds, about every 1 second to about every 4 seconds, about every 1 second to about every 5 seconds, about every 1 second to about every 6 seconds, about every 1 second to about every 7 seconds, about every 1 second to about every 8 seconds, about every 1 second to about every 9 seconds, about every 1 second to about every 10 seconds, about every 2 second to about every 5 seconds, about every 3 second to about every 7 seconds, about every 4 second to about every 5 seconds, about every 5 second to about every 10 seconds, about every 10 second to about every 15 seconds, about every 15 second to about every 30 seconds, about every 0.1 seconds, about every 0.2 seconds, about every 0.3 seconds, about every 0.4 seconds, about every 0.5 seconds, about every 0.6 seconds, about every 0.7 seconds, about every 0.8 seconds, about every 0.9 seconds, about every 1 second, about every 1.5 seconds, about every 2 seconds, about every 3 seconds, about every 4 seconds, about every 5 seconds, about every 6 seconds, about every 7 seconds, about every 8 seconds, about every 9 seconds, about every 10 seconds, about every 11 seconds, about every 12 seconds, about every 13 seconds, about every 14 seconds, about every 15 seconds, about every 20 seconds, about every 30 seconds, about every 45 seconds, about every 60 seconds, about every 75 seconds, about every 90 seconds, about every 105 seconds, or about every 120 seconds).

In some embodiments, pressure applied to the breast cup (2) changes gradually. In some embodiments, pressure applied to the breast cup (2) changes at different rates, e.g., in a first cycle the pressure applied to the breast cup (2) changes over about 0.1 seconds to about 120 seconds (e.g., about 1 second), and in a second cycle the pressure applied to the breast cup (2) changes over about 0.1 seconds to about 120 seconds (e.g., about 5 seconds).

Pressure within the breast cup (2) can provide a pulsating or massaging sensation. In some embodiments, the speed and pressure of the pulsation or massage may be selected by the user. In some embodiments, alternating pressure mimics the action of suckling.

Breast Cup

An exemplary breast cup (2) is shown in FIG. 14 . The breast cup may include a housing (17), a breast shield (19), and a diaphragm (18) disposed between the housing (17) and the breast shield (19), such that the diaphragm (18) separates a pressure chamber (20) from a milk chamber (21). In some embodiments, the breast cup (2) includes a milk chamber wall (26), e.g., as shown in FIG. 20 . The milk chamber wall (26) can be disposed between the diaphragm (18) and the breast shield (19), thereby defining the milk chamber (21) between the diaphragm (18) and the milk chamber wall (26). Pressurization and/or depressurization of the pressure chamber (20) deforms the diaphragm (18), and thereby expands or compresses the milk chamber (21). The pressure chamber is not fluidically connected to the milk chamber or breast shield. In some embodiments, the pressure chamber is not in fluidic communication with the milk chamber or breast shield.

One or more of the components of the breast cup (2), including the housing (17), the diaphragm (18), the breast shield (19), and/or the milk chamber wall (26) may be removably attached to the breast cup (2). In some embodiments, the pressure chamber (20) and/or the milk chamber (21) are distinct reservoirs, as opposed to chambers formed from the space between other components (e.g., the housing (17), the diaphragm (18), the milk chamber wall (26), and/or the breast shield (19), and may be reversibly attached to the breast cup (2). For example, the milk chamber (21) may be removed from the breast cup (2) to be cleaned or replaced.

In some embodiments, at least one of the housing (17), the diaphragm (18), the breast shield (19), and/or the milk chamber wall (26) can include a protrusion and/or a recess, such as a groove. In some embodiments, a protrusion on at least one of the housing (17), the diaphragm (18), the breast shield (19), and/or the milk chamber wall (26) is configured to mate with a recess, such as a groove, on at least one of the housing (17), the diaphragm (18), the breast shield (19), and/or the milk chamber wall (26). Mating between a protrusion and a recess, e.g., groove, allows two components to be snapped, slid, or friction-fit together. FIG. 20 shows an embodiment of the breast cup (2), in which the housing (17), the diaphragm (18), the breast shield (19), and/or the milk chamber wall (26) are attached together at least partially using protrusions and recesses, e.g., grooves.

Alternatively, or in addition, at least one of the housing (17), the diaphragm (18), the breast shield (19), and/or the milk chamber wall (26) can be attached together using any other suitable connector, e.g., an adhesive (e.g., glue) or a fastener (e.g., a screw). FIGS. 26A-26D show an embodiment of the breast cup (2), in which the housing (17), the diaphragm (18), the breast shield (19), and/or the milk chamber wall (26) are attached together at least partially using a fastener.

The breast cup (2), e.g., via the breast shield (19), contacts the breast of the user and can provide a seal during breast pumping, such that milk does not leak. The breast cup (2), the breast shield (19), and/or the housing (17) are configured to conform to the breast comfortably for frequent and/or long periods of wear, such that the breast is not irritated. For example, the interior of the breast cup (2), e.g., the breast shield (19), may conform to the breast and/or the nipple of the user.

The breast cup (2), the breast shield (19), and/or the housing (17) may be in a shape for improved conformance to the breast, e.g., a funnel, a cone, or a dome. The exterior of the breast cup (2) may be rounded. A rounded breast cup (2) may appear breast-like, e.g., to be worn discreetly under clothing. The breast cup (2), the breast shield (19), and/or the housing (17) may be toroidal, e.g., forming a ring, with the breast cup (2), the breast shield (19), and/or the housing (17) covering the breast.

In some embodiments, the breast cup (2) is funneled. The breast cup (2) may include a wide portion (8) and a nipple tunnel (13), e.g., as shown in FIG. 14 , in which the wide portion (8), e.g., of the breast cup (19), initially contacts the breast, and the nipple tunnel (13), e.g., of the breast cup (19), is configured to receive the nipple.

The wide portion (8) of the breast cup (2) may have a largest diameter from about 50 mm to about 250 mm (e.g., about 50 mm to about 75 mm, about 50 mm to about 100 mm, about 50 mm to about 125 mm, about 50 mm to about 150 mm, about 50 mm to about 75 mm, about 75 mm to about 100 mm, about 75 mm to about 125 mm, about 75 mm to about 150 mm, about 75 mm to about 175 mm, about 75 mm to about 200 mm, about 100 mm to about 125 mm, about 100 mm to about 150 mm, about 100 mm to about 175 mm, about 100 mm to about 200 mm, about 125 mm to about 150 mm, about 125 mm to about 175 mm, about 125 mm to about 200 mm, about 150 mm to about 175 mm, about 150 mm to about 200 mm, about 150 mm to about 250 mm, or about 200 mm to about 250 mm). The nipple tunnel (13) of the breast cup (2) may have a largest diameter greater than 25 mm (e.g., greater than 50 mm, 75 mm, 100 mm, 125 mm, 150 mm, 175 mm, 200 mm, 225 mm, or 250 mm).

The breast cup (2), the breast shield (19), and/or the housing (17) may include a gel such that it allows better conformance to the breast. In some embodiments, the breast cup (2) conforms to the breast and supports the weight of the breast cup (2) and fluid conduits extending from the breast cup (2) without additional adhesives, gels, straps, or bras. In some embodiments, the breast cup (2) secures to a garment, such as a bra or shirt.

The breast cup (2), the breast shield (19), and/or the housing (17) may include a food contact substance. Additionally, or alternatively, the breast cup (2), the breast shield (19), and/or the housing (17) may include an infant grade material. The breast cup (2), the breast shield (19), and/or the housing (17) may include a flexible material, e.g., formed from a polymeric material such as silicone. The breast cup (2), the breast shield (19), and/or the housing (17) may include a rigid material. The breast cup (2), the breast shield (19), and/or the housing (17) may include PET, PVC, PTFE, polyethylene, HDPE, LDPE, copolyester (e.g., Tritan EX401), PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, PVDF, or silicone. In some embodiments, breast cup (2), the breast shield (19), and/or the housing (17) can include a fabric (e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill).

In some embodiments, the breast cup (2) may be in fluidic communication with the negative pressure source (9), such that milk is pumped from the breast to the reservoir (3).

In some embodiments, the breast cup (2) may have a second fluidic conduit providing fluidic communication between the breast cup (2) and the negative and/or positive pressure source (9). In some embodiments, the breast cup (2) may have a first fluidic conduit providing fluidic communication between the breast cup (2) and a reservoir (3) or manifold (29). In some embodiments the first fluidic conduit is releasably connected to the breast cup (2) via a first outlet on the breast cup (2), e.g., from the milk chamber. In some embodiments, the second fluidic conduit is releasably connected to the breast cup (2) via an inlet to the breast cup (2), e.g., in the pressure chamber. In some embodiments, the first and second fluidic conduits are releasably connected to the breast cup (2) via a connector, e.g., wherein the inlet and outlet to which the first fluidic conduit and the second fluidic conduit connect are not disposed adjacent to each other. In some embodiments, the connector further comprises a half moon shape.

In some embodiments, the breast cup (2) allows for the extension of the nipple when negative pressure is supplied, e.g., by the negative pressure source (9) e.g., at a first pressure, in order to express milk. When positive pressure is supplied by a control valve (10) and/or a positive pressure source, e.g., at a second pressure, the nipple contracts, and reduces or stops milk flow until a higher negative pressure is supplied.

In some embodiments, the interior of the breast cup (2), e.g., the interior of the breast shield (19), includes an open area, e.g., the nipple tunnel (13), dimensioned to allow for clearance and space in front of the nipple to permit milk to exit the nipple even when the nipple is pulled forward by suction.

In some embodiments, the breast pump system (1) includes two breast cups (2), e.g., one for each breast. In embodiments in which the breast pump system includes two breast cups (2), the two breast cups (2) can each include a housing (17), a breast shield (19), and a diaphragm (18). A user can use both of the breast cups (2) at the same time, or just one of the two at any given time.

One or more components of the breast cup may be clear to allow for visualization of the nipple, e.g., for alignment, during placement. The breast cup may also include an opaque cover or flat to make the nipple not visible after placement of the breast cup. The breast cup may also include a lens to magnify the nipple to aid in alignment.

Breast Shield

The breast cup (2) can include a breast shield (19), e.g., as shown in FIGS. 26A-26D. The breast shield (19) contacts the breast of the user and can provide an airtight seal during breast pumping, such that milk does not leak from the breast cup (2). The breast shield (19) is configured to conform to the breast comfortably for frequent and/or long periods of wear, such that the breast is not irritated. The breast shield (19) can include a wide portion and a nipple tunnel, in which the wide portion initially contacts the breast, and the nipple tunnel is configured to receive the nipple. For example, the breast shield (19) can conform to the breast and provide space for the nipple, e.g., in the nipple tunnel.

In some embodiments, the nipple tunnel has a length from about 5 mm to about 75 mm (e.g., about 5 mm to about 10 mm, about 5 mm to about 20 mm, about 5 mm to about 30 mm, about 5 mm to about 40 mm, about 5 mm to about 50 mm, about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about 10 mm to about 70 mm, about 25 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 75 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, or about 75 mm).

In some embodiments, the nipple tunnel has a minimum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about 10 mm to about 70 mm, about 10 mm to about 100 mm, about 25 mm to about 50 mm, about 25 mm to about 75 mm, about 30 mm to about 130 mm, about 50 mm to about 75 mm, about 50 mm to about 130 mm, about 70 mm to about 130 mm, about 100 mm to about 130 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, about 75 mm, about 80 mm, about 90 mm, about 100 mm, about 110 mm, about 120 mm, about 125 mm, or about 130 mm). In some embodiments, the diameter of the nipple tunnel is between about 20 and about 40 mm.

In some embodiments, the nipple tunnel has a maximum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about 10 mm to about 70 mm, about 10 mm to about 100 mm, about 25 mm to about 50 mm, about 30 mm to about 130 mm, about 25 mm to about 75 mm, from about 50 mm to about 75 mm, about 50 mm to about 130 mm, about 70 mm to about 130 mm, about 100 mm to about 130 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, about 75 mm, about 80 mm, about 90 mm, about 100 mm, about 110 mm, about 120 mm, about 125 mm, or about 130 mm).

In some embodiments, the diameter of the nipple tunnel is between about 11 and 30 mm.

The breast shield (19) can be in a shape for improved conformance to the breast, e.g., a funnel, a cone, or a dome. The breast shield (19) can be rounded or toroidal, e.g., forming a ring.

The breast shield (19) can include an inlet to the milk chamber (21), such that milk may enter the milk chamber (21) once expressed from the nipple. In some embodiments, the diaphragm (18) releasably contacts the inlet, e.g., at a sealing point (23), providing a seal when negative pressure is not applied to the pressure chamber. Thus, in some embodiments, the diaphragm (18) releasably seals the inlet. The releasable sealing of the inlet to the milk chamber (21) is shown in FIG. 17 .

In some embodiments, the inlet includes a valve, e.g., an umbrella valve (24), e.g., as shown in FIG. 18 , or a non-drip valve. In some embodiments, the valve is a mechanical valve, an umbrella valve (24), a butterfly valve, a disk valve, or a duckbill valve.

In some embodiments, the inlet includes at least one orifice (25), e.g., as shown in FIG. 19 . In some embodiments, the inlet includes a plurality of orifices (25). In some embodiments, the plurality of orifices (25) are circumferentially arranged at the nipple tunnel of the breast shield (19), e.g., as shown in FIG. 19 . In some embodiments, the diaphragm (18) releasably contacts at least one of the orifices (25), e.g., at sealing point (23), providing a seal when negative pressure is not applied to the pressure chamber (20). In some embodiments, the diaphragm (18) contacts the plurality of orifices (25). Thus, in some embodiments, the diaphragm (18) releasably seals at least one orifice, e.g., at sealing point (23). In some embodiments, the diaphragm (18) seals the plurality of orifices (25), e.g., at sealing point (23). In some embodiments, the diaphragm (18) releasably contacts the breast cup (19) at a point as to separate the at least one orifice (25) from the milk chamber (21).

In some embodiments, the orifice (25) can have a diameter from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 1 mm to about 10 mm, about 3 mm to about 7 mm, about 5 mm to about 10 mm, about 8 mm to about 10 mm, about 1mm, about 2mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm).

In some embodiments, the diaphragm (18) is not configured to contact the inlet, e.g., at sealing point (23). In some embodiments, the breast cup (2), e.g., the breast shield (19) includes a fitting which may seal the inlet from the milk chamber (21). In some embodiments, the fitting is a plug or a cover.

The wide portion of the breast shield (19) can seal to the breast, while the nipple tunnel provides room for the nipple to be expanded to express milk. In some embodiments, the wide portion of the breast shield (19) seals to the breast, e.g., around the base of nipple. In some embodiments, the breast shield (19) is sealed to the breast before a breast pumping session commences.

In some embodiments, a positive or negative pressure may be applied to the breast cup (2) prior to a breast pumping session to contract the breast shield (19), e.g., the wide portion of the breast shield (19), such that the breast shield (19) may be sealed to the breast. Following a breast pumping session, a positive or negative pressure may be applied to the breast cup (2) such that the breast cup (2), e.g., the wide portion of the breast shield (19), may be unsealed from the breast. In some embodiments, the edge of the wide portion of the breast shield (19) solely contacts the breast before application of negative pressure. Following application of negative pressure to the breast cup (2), substantially all of the wide portion of the breast shield (19) may contact the breast.

Negative pressure can be applied to the breast cup (2) for sealing of the breast cup (2) to the breast from the negative pressure source (9), or from force applied manually from the user to the breast cup (2), e.g., to the housing (17). For example, the user may push on the breast cup (2), e.g., the housing (17), to provide negative pressure to the breast shield (19) and seal the breast cup (2) to the breast. Positive pressure can be applied to the breast cup (2) to unseal the breast cup (2) from the breast from the positive pressure source, from a valve to the ambient atmosphere, from a slow leak, or from force manually applied from the user to the breast cup (2). For example, a user may pull on the breast cup (2), e.g., the housing (17), to provide positive pressure to the breast shield (19) and unseal the breast cup (2) from the breast. In some embodiments, the breast cup (2) includes an air pocket, to which negative or positive pressure can be applied to seal or unseal the breast cup (2) to the breast.

The inside of the breast shield (19) can include at least one protrusion (27) to improve sealing of the breast shield (19) to the breast. FIG. 21A and FIG. 21 B show embodiments of the breast shield (19) having protrusions (27). In some embodiments, the protrusion (27) is a toroidal ridge, see, e.g., FIG. 21A. In some embodiments, the protrusion (27) is a curved toroidal ridge, see, e.g., FIG. 21B. In some embodiments, the outer surface of the breast shield (19) includes an indent to form the protrusion (27) on the inner surface of the breast shield (19), see, e.g., FIG. 21A.

Sealing of the breast shield (19) to the breast may keep milk from leaking around the breast and improve security of the breast shield (19) to the breast during breast pumping. Unsealing of the breast shield (19) from the breast when a breast pumping session is not ongoing, e.g., to allow air flow, may improve comfort, reduce skin temperature, and reduce sweat build-up. Furthermore, expansion and contraction of breast shield (19) allows for the breast shield (19) to fit breasts of a plurality of sizes, e.g., AA cup, A cup, B cup, C cup, D cup, DD cup, DDD cup, E cup, F cup, etc.

The ability to expand and contract the nipple tunnel of the breast shield (19), mechanically or using pressure, may be advantageous in setting up the breast pump system (1) for breast pumping. In some embodiments, the internal diameter of the nipple tunnel of breast shield (19) is reduced slowly while moving the breast shield (19) into position, such that the user may be able to center the breast shield (19) on their nipple via touch and feel without the need for line of sight. In some embodiments, the housing (17) and diaphragm (18) may be or may include a clear material, such that the user may additionally use line of sight to center the breast shield (19) on their nipple.

In some embodiments, the breast shield (19) and/or the housing (17) include ridges, bumps, and/or dimples. In some embodiments, an internal surface of the breast shield (19) and/or the housing (17) include ridges, bumps, or dimples. Ridges, bumps, and/or dimples may aid in aligning the breast cup (2) to the breast, adherence of the breast cup (2) to skin, reduction of heat build-up, and may provide further comfort when a user is wearing the breast cup. In some embodiments, the ridges, bumps, and/or dimples include foam.

In some embodiments, the ridge includes a straight ridge, a curved ridge, a zig-zag ridge, an undulating ridge, a spiral ridge, a continuous ridge, or a broken ridge. The breast shield (19) can include a plurality of ridges. In some embodiments, the ridges are from about 1 mm to about 100 mm apart (e.g., about 1 mm to about 2 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 25 mm, about 1 mm to about 50 mm, about 5 mm to about 10 mm, about 10 mm to about 25 mm, about 10 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 100 mm, about 1 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, about 70 mm, about 75 mm, about 80 mm, about 90 mm, or about 100 mm).

Air may flow between the ridges, bumps, and/or dimples where the surface of the breast shield (19) does not contact the breast. In some embodiments, the ridges, bumps, and/or dimples extend from an edge of the breast shield (19) to an inner point of the inner surface of the breast shield (19). In this regard, the ridges, bumps, and/or dimples may form an air passage from the ambient atmosphere to the inner surface of the breast shield (19). Thus, in some embodiments, the breast shield (19) includes a fluid conduit, wherein the fluid conduit may be defined by the (i) ridges, bumps, and/dimples, (ii) the skin of the breast, and (iii) the inner surface of the breast shield (19). The fluid conduit may create a chimney effect resulting in the advantage of improved air circulation in the breast shield (19).

Alternatively, or additionally, the breast cup (2) may be manually pressed in order to expel air from the breast shield (19). Following release of the breast cup (2), fresh air may flow back into the breast shield (19). In some embodiments, this method of circulating air in the breast shield (19) may be accomplished before or following a breast pumping session. For example, a spiral ridge on the inner surface of the breast shield (19) may form a fluid conduit with the skin of the breast. When the breast cup (2) is pressed, air inside the breast shield (19) may be transported around the spiral to the ambient atmosphere. When the pressure is removed from the breast cup (2), fresh air may be transported around the spiral back into the breast shield (19).

Ridges, bumps, and/or dimples may also reduce the peeling effect when removing the breast cup (2). A reduction in peeling effect can improve comfort, especially for those users with sensitive skin.

The breast shield (19) may include a material which becomes soft by heating and further conforms to the geometry of the body. The breast shield (19) can include one or more formable chambers, which aid in conforming the breast shield (19) to the breast of the user. In some embodiments, the formable chambers include a fluid, e.g., a gas or liquid. In some embodiments, the breast shield (19) includes flexible, gel-like materials such as cross-linked silicone. In some embodiments, the breast shield (19) includes one or more thixotropic fluids.

In some embodiments, breast shield (19) includes a material which may store heat for improved comfort. In some embodiments, the breast shield (19) includes a material which may expel heat into the ambient environment. In some embodiments, the breast shield (19) includes regions of material which may store heat, and regions of material which may expel heat. In some embodiments, the regions of material which may expel heat include regions having ridges, bumps, and/or dimples.

The breast shield (19) can include a food contact substance. Alternatively, or additionally, the breast shield (19) can include an infant grade material. The breast shield (19) can include polyvinyl chloride (PVC), polyethylene, PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, polyvinylidene fluoride (PVDF), or silicone. The breast shield (19) can include a flexible material, e.g., formed from a polymeric material such as silicone. The breast shield (19) can include a rigid material. In some embodiments, the breast shield (19) includes a water-resistant or a sweat-resistant material.

In some embodiments, two human breasts are contacted with two breast shields (19) to pump milk from both breasts.

Housing

The breast cup (2) may include a housing (17). The housing (17) may be disposed on the exterior of breast cup (2), e.g., around the breast cup (2), e.g., be outward facing. The housing (17) may form a portion of the outer surface of the pressure chamber (20) or be a separate component.

In some embodiments, the housing (17) may be disposed around the wide portion (8) of the breast shield (19), e.g., the first point of contact with the breast. The housing (17) may conform to the breast. The housing (17) may include a gel such that it conforms to the breast. In some embodiments, the housing (17) conforms to the breast and supports the weight of the breast cup (2), the housing (17), and fluid conduits (5) extending from the breast cup (2) without additional adhesives, gels, straps, or bras.

In some embodiments, the housing (17) does not conform to the breast. The housing (17) may secure to a garment, such as a bra or shirt.

The housing (17) may serve a plurality of additional purposes including improved conformance of the breast cup (2) to the breast, improved comfort of the breast pump system (1), releasable attachment of the breast cup (2) to a garment, and/or blocking the breast from view while using the breast pump system (1).

The housing (17) can include a food contact substance. In some embodiments, the housing (17) can include a flexible material, e.g., formed from a polymeric material such as silicone. In some embodiments, the housing (17) can include a rigid material. In some embodiments, the housing (17) can include a fabric (e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill). The housing (17) can include polyvinyl chloride (PVC), PTFE (e.g., Teflon), polyethylene, HDPE, LDPE, copolyester (e.g., Tritan EX401PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, polyvinylidene fluoride (PVDF), or silicone. In some embodiments, the housing (17) can include a clear material.

Diaphragm

The breast cup (2) may include a diaphragm (18). The diaphragm (18) may separate the pressure chamber (20) from the milk chamber (21).

The diaphragm (18) is configured to deform, i.e., expand, contract, or balloon, under pressure.

Upon application of negative pressure to the pressure chamber (21), the diaphragm (18) may deform away from the inlet to the milk chamber (21), opening the inlet to the milk chamber (21). The breast cup (2) including the diaphragm (18) is advantageous in that the configuration may aid in providing fluid flow under pressure, as opposed to exclusively relying on gravity, such that a subject may breast pump in a reclined position.

In some embodiments, the diaphragm (18) includes a flexible material that may stretch upon depressurization and pressurization of the pressure chamber. Alternatively, the diaphragm (18) includes a folded, or otherwise shaped, material, which may unfold and refold upon depressurization and pressurization of pressure chamber (20). In some embodiments, the diaphragm (18) includes from 1 to 10 folds (e.g., 1 to 2,1 to 3, 1 to 4,1 to 5,1 to 6, 1 to 7,1 to 8,1 to 9, 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 8, 3 to 4, 3 to 5, 3 to 7, 4 to 5, 4 to 6, 4 to 10, 5 to 8, 5 to 10, 8 to 10, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10). In some embodiments, the folded, or otherwise shaped, material is toroidal. In some embodiments, the folded, or otherwise shaped, material may unfold in either direction. In other embodiments, the folded, or otherwise shaped, material may unfold only towards the pressure chamber (20) or milk chamber (21). Flexible and/or folded diaphragms are advantageous in that they allow for expansion with smaller footprints.

In some embodiments, the diaphragm (18) includes a patterned material, such as including a plurality of indents or grooves. A diaphragm including a patterned material may be advantageous in optimizing interaction with the pressure chamber (20) and/or the milk chamber (21). In some embodiments, a first portion of the diaphragm (18) includes a plurality of indents and/or grooves. In some embodiments, the first portion of the diaphragm (18), which includes the plurality of indents and/or grooves, can deform more than a second portion of the diaphragm (18) which does not include a plurality of indents and/or grooves.

In some embodiments, the diaphragm (18) includes a material having a shore hardness from A10 to A80 (e.g., A10, A20, A30, A40, A50, A60, A70, or A80). In some embodiments, the diaphragm (18) includes a material having a shore hardness from D10 to D80 (e.g., D10, D20, D30, D40, D50, D60, D70, or D80).

In some embodiments, the diaphragm (18) includes a thickness from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 5 mm to about 10 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm). The diaphragm may have a non-uniform thickness, e.g., with a thicker portion to seal an inlet or at the edge to seal to other components.

In some embodiments, the diaphragm (18) is configured to seal the inlet to the milk chamber (21) at sealing point (23). Sealing between the diaphragm (18) and the inlet may be improved through optimization of the shore hardness, rigidity, thickness, material, surface conditions, and shape of the diaphragm (18).

In some embodiments, the diaphragm (18) varies in thickness and/or shore hardness. The diaphragm (18) may include a higher thickness and/or higher shore hardness in the portion of the diaphragm (18) which overlaps with the inlet of the milk chamber (21), e.g., at sealing point (23). In some embodiments, the diaphragm (18) includes a first thickness from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 1 mm to about 10 mm, about 1 mm to about 12 mm, about 1 mm to about 15 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm), and a second thickness from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 1 mm to about 10 mm, about 1 mm to about 12 mm, about 1 mm to about 15 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm), in which diaphragm (18) includes the second thickness where diaphragm (18) contacts the inlet, e.g., at sealing point (23). In some embodiments, the diaphragm (18) includes a material having a first shore hardness from A10 to A80 (e.g., A10, A20, A30, A40, A50, A60, A70, or A80) and a second shore hardness, different from the first, from A10 to A80 (e.g., A10, A20, A30, A40, A50, A60, A70, or A80) or being rigid, in which the material includes the second shore hardness where diaphragm (18) contacts the inlet, e.g., at sealing point (23). In this embodiment, the second shore hardness may further range from D10 to D80 (e.g., D10, D20, D30, D40, D50, D60, D70, or D80) or be rigid.

In some embodiments, the diaphragm (18) includes a curved shape, such that the surface of the diaphragm (18) curves over and around the inlet to the milk chamber (21). In some embodiments, the diaphragm (18) includes a parabolic shape on the side of the diaphragm that contacts the inlet. In some embodiments, the diaphragm (18) may have a cup or cone shape.

In some embodiments, the diaphragm (18) includes a plurality of layers, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10. In some embodiments, the diaphragm (18) includes a plurality of layers in which the diaphragm (18) contacts the inlet, e.g., at sealing point (23). In some embodiments, a second layer is over molded over a first layer of the diaphragm (18). The first layer and/or second layer may be a flexible or rigid material. In some embodiments, the first layer is a rigid material, and the second layer is a flexible material. This embodiment may be advantageous in sealing the inlet, such that the rigid material maintains coverage of the entire inlet, while the flexible material aids in sealing the sealing point (23). The first layer may be a disk and/or may include a ring or lip to aid in sealing. Alternatively, the first layer may be a cup or cone shaped layer over molded or embedded into the diaphragm (18). In some embodiments, the cup or cone shaped layer is configured to cap the inlet to the milk chamber (21), e.g., at sealing point (23). A plurality of layers may aid decreasing deflection and improving sealing performance at the point where the diaphragm (18) contacts the inlet of the milk chamber, e.g., at sealing point (23). In some embodiments, all or a portion of the diaphragm may be clear. In some embodiments, a clear portion may be configured to seal the inlet to the milk chamber (21), e.g., at the sealing point, and may provide a visual line of sight from the outside of the diaphragm (18) to the nipple tunnel (13). In this embodiment, the clear portion may contain a lens, wherein the lens allows for magnification. A visual line of sight to the nipple chamber may aid the user in centering the breast shield (19) on the nipple during a pumping session.

In some embodiments, the diaphragm (18) is shaped to conform to the shape of the breast shield (19), e.g., upon compression of the milk chamber (21). In some embodiments, the diaphragm (18) is not configured to contact the inlet, e.g., at sealing point (23). In some embodiments, the fitting is a plug or a cover. In some embodiments, the diaphragm (18) is configured to actuate a valve (24).

The diaphragm (18) can include a food contact substance. The diaphragm (18) can include polyvinyl chloride (PVC), polyethylene, PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, polyvinylidene fluoride (PVDF), or silicone. The diaphragm (18) can include a flexible material, e.g., formed from a polymeric material such as silicone. The diaphragm (18) can include a rigid material.

Milk Chamber

The breast cup (2) can include the milk chamber (21), which is configured to temporarily hold a volume of milk that is expressed from a nipple. The milk chamber (21) includes an inlet and an outlet (22).

In some embodiments, the milk chamber (21) is reversibly attached to the breast cup (2). In some embodiments, the milk chamber (21) is reversibly attached to the breast cup (2), such that smaller or larger milk chambers (21) may be reversibly attached to the breast cup (2).

The milk chamber (21) can have a volume, nominal or expanded, from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 25 mL, about 1 mL to about 50 mL, about 1 mL to about 75 mL, about 1 mL to about 100 mL, about 25 mL to about 50 mL, about 25 mL to about 100 mL, about 50 mL to about 150 mL, about 100 mL to about 150 mL, about 1 mL, about 5 mL, about 10 mL, about 15 mL, about 20 mL, about 25 mL, about 30 mL, about 40 mL, about 50 mL, about 60 mL, about 70 mL, about 75 mL, about 80 mL, about 90 mL, about 100 mL, about 125 mL, or about 150 mL). The milk chamber (21) can have a maximum volume, nominal or expanded, from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 25 mL, about 1 mL to about 50 mL, about 1 mL to about 75 mL, about 1 mL to about 100 mL, about 25 mL to about 50 mL, about 25 mL to about 100 mL, about 50 mL to about 150 mL, about 100 mL to about 150 mL, about 1 mL, about 5 mL, about 10 mL, about 15 mL, about 20 mL, about 25 mL, about 30 mL, about 40 mL, about 50 mL, about 60 mL, about 70 mL, about 75 mL, about 80 mL, about 90 mL, about 100 mL, about 125 mL, or about 150 mL). In some embodiments, the milk chamber (21) has a nominal volume of less than about 10 mL (e.g., less than about 5 mL, less than about 4.5 mL, less than about 4 mL, less than about 3.5 mL, less than about 3 mL, less than about 2.5 mL, less than about 2 mL, less than about 1.5 mL, less than about 1 mL, less than about 0.5 mL, or less than about 0.1 mL). In some embodiments, the milk chamber has a nominal volume of about 30 mL.

In some embodiments, the diaphragm (18) seals the inlet to the milk chamber (21) before positive pressure, e.g., at ambient pressure, is applied to pressure chamber (20) and the milk chamber (21) is compressed, e.g., at sealing point (23). In some embodiments, the seal between the diaphragm (18) and the inlet to the milk chamber (21) has greater sealing pressure than that resistance of one directional valve on the outlet of the milk chamber (21).

As described herein, the milk chamber may be formed by the space between the breast shield and the diaphragm or between one or more additional layers between the diaphragm and the breast shield.

The milk chamber may include an outlet. The outlet may include a one directional valve, e.g., to prevent air or expressed milk from being drawn back into the milk chamber during milk expression. The valve opens to allow milk to flow out of the milk chamber. In some embodiments, the one directional valve is passively actuated by pressure changes in the milk chamber. The milk chamber may also include an inlet, e.g., as a vent or to allow additional fluids, e.g., cleaning fluids or positive pressure to enter.

Milk Chamber Wall

The breast cup (2) may include a milk chamber wall (26).

While in some embodiments, the milk chamber (21) is defined between the diaphragm (18) and the breast shield (19), the milk chamber (21) can alternatively be defined between the diaphragm (18) and the milk chamber wall (26), e.g., as shown in FIG. 20 . Thus, in some embodiments, the milk chamber wall (26) is disposed between the diaphragm (18) and the breast shield (19), thereby defining the milk chamber (21) between the diaphragm (18) and the milk chamber wall (26). The milk chamber wall is advantageous, in that it can provide additional structural stability to the milk chamber.

In some embodiments, the milk chamber wall (26) can include a curved shape or a cup-shape.

In some embodiments, the milk chamber wall (26) is removably attached to the breast cup (2). In some embodiments, the milk chamber wall (26) is snapped into the breast cup (2). In some embodiments, the milk chamber wall (26) can be inserted into the breast cup (2) to reduce the volume of the milk chamber (21).

In some embodiments, the milk chamber wall (26) includes an orifice for outlet (22).

In some embodiments, the milk chamber wall (26) can include polyethylene terephthalate (PET), polypropylene (PP), polyethylene, high-density polyethylene (HDPE), low-density polyethylene (LDPE), or polycarbonate (PC). The milk chamber wall may include a clear material.

Pressure Chamber

The breast cup (2) can include the pressure chamber (20), which is configured to expand and compress the diaphragm (18) in order to express milk from a nipple.

In some embodiments, the pressure chamber (20) is reversibly attached to the breast cup (2).

The pressure chamber (20) can have a maximum volume from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 15 mL, about 1 mL to about 20 mL, about 1 mL to about 25 mL, about 1 mL to about 50 mL, about 1 mL to about 75 mL, about 1 mL to about 100 mL, about 5 mL to about 10 mL, about 5 mL to about 15 mL, about 5 mL to about 20 mL, about 5 mL to about 25 mL, about 5 mL to about 50 mL, about 10 mL to about 15 mL, about 10 mL to about 20 mL, about 10 mL to about 25 mL, about 10 mL to about 30 mL, about 10 mL to about 50 mL, about 15 mL to about 20 mL, about 15 mL to about 25 mL, about 15 mL to about 30 mL, about 15 mL to about 50 mL, about 20 mL to about 25 mL, about 20 mL to about 30 mL, about 20 mL to about 50 mL, about 25 mL to about 50 mL, from about 25 mL to about 100 mL, from about 50 mL to about 150 mL, from about 100 mL to about 150 mL, about 1 mL, about 5 mL, about 6 mL, about 7 mL, about 8 mL, about 9 mL, about 10 mL, about 11 mL, about 12 mL, about 13 mL, about 14 mL, about 15 mL, about 16 mL, about 17 mL, about 18 mL, about 19 mL, about 20 mL, about 25 mL, about 30 mL, about 40 mL, about 50 mL, about 60 mL, about 70 mL, about 75 mL, about 80 mL, about 90 mL, about 100 mL, about 125 mL, or about 150 mL). The pressure chamber may have a maximum volume of about 45 mL.

In some embodiments, the pressure chamber (20) limits the shape of the diaphragm (18) at the maximum deflection of the diaphragm (18), thus restricting the maximum negative pressure that can be applied to the nipple.

In some embodiments, upon application of positive pressure, the diaphragm (20) moves towards its nominal position and extends past it under pressure to conform to the shape of the milk chamber (21), thus transporting all liquid through the outlet (22).

In some embodiments, the pressure chamber (20) further includes a valve to the ambient atmosphere. In some embodiments, the valve is an inflation valve. In some embodiments, volume of the pressure chamber (20) may be set with the inflation valve. In some embodiments, the valve is a relief valve. The relief valve may be configured to release pressure from the pressure chamber (20) if the positive pressure exceeds a maximum positive pressure, or if the negative pressure exceeds a maximum negative pressure.

While in some embodiments, the volume of the pressure chamber (20) may be set with an inflation valve, the volume of the pressure chamber (20) may be set in a variety of manners. In some embodiments, the pressure chamber (20) is reversibly attached to the breast cup (2), such that smaller or larger pressure chambers (20) may be reversibly attached to the breast cup (2). In some embodiments, the breast cup includes a plug, which may be configured to be inserted into the pressure chamber (20) to reduce the volume. In some embodiments, the volume of the pressure chamber (20) may be adjusted manually by the user such that it sits further or closer to the chest of the user.

The pressure chamber (20) can be returned to ambient pressure following a breast pumping session.

The pressure chamber (20) includes one or more inlets to allow for changes in pressure. The pressure chamber or housing may include a limiter that controls the maximum volume of the pressure chamber, e.g., to determine the pressure limit. For example, the breast shield may include a bladder or other element that can be filled with air or other fluid, e.g., water, and disposed to reduce the volume available for expansion of the pressure chamber.

Milk Distribution System

The United States Food and Drug Administration (FDA) advises against mixing freshly expressed breast milk with already cooled or frozen milk as it can rewarm the older stored milk. The FDA also advises against storing milk at room temperature for more than 4 hours. Thus, it is advantageous to have a breast pump system (1) that can provide for multiple breast pumping sessions without the removal of a breast cup (2), as well as divert milk to different reservoirs (3) from a plurality of breast pumping sessions. The present disclosure provides a milk distribution system, e.g., a breast milk distribution system (28). The milk distribution system is advantageous in that it may facilitate repeated breast pumping without the removal of a breast cup (2) from a breast and/or without the replacement of a reservoir (3) from a breast pump system (1). The presently disclosed breast pump system (1) may include the milk distribution system (28).

In some embodiments, the milk distribution system (28) can include a breast cup (2) and a manifold (29) comprising an inlet (30) and a plurality of outlets (31), e.g., as shown in FIG. 22 . Each outlet (31) may provide fluidic communication to a different reservoir (3).

Alternatively, the manifold (29) can include an inlet (30) and an outlet (31), in which the outlet (31) is configured to provide fluidic communication to a plurality of reservoirs (3). In some embodiments, the milk distribution system (28) includes a manifold (29) in fluidic communication with the breast cup (2), wherein the manifold (29) includes an inlet (30) and an outlet (31) configured to move from a first position to a second position, e.g., as shown in FIG. 23 .

In some embodiments, the milk distribution system (28) includes a plurality of reservoirs (3), e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20. In some embodiments, the milk distribution system (28) can include a manifold (29) comprising an inlet (30) and a plurality of outlets (31), wherein each outlet (31) comprises a valve (24); and a plurality of reservoirs (3), wherein each of the plurality of reservoirs (3) is in fluidic communication with a different outlet (31).

In some embodiments, the milk distribution system (28) is configured to distribute milk from a plurality of breast pumping sessions based on a pre-programmed pumping schedule input by a user. In some embodiments, milk from a first pre-programmed breast pumping session of the pre-programmed pumping schedule is transported to a first reservoir (3), and milk from a second pre-programmed breast pumping session of the pre-programmed pumping schedule is transported to a second reservoir (3). Different pumping sessions may be spaced apart by time, e.g., 3-4 hours.

Pumping milk to the milk distribution system may occur by the action of the diaphragm. Other pumping mechanisms may also be employed, including providing positive pressure to the milk chamber, e.g., by forced air or providing negative pressure to a fluid conduit between the milk chamber and a reservoir. Negative pressure may be employed by a peristaltic pump or by air being pulled into the fluid conduit. These may also act to flush the conduit after a pumping session or after a set number of pumping session. For example, a flush line may connect to the fluid conduit, with both the flush line and the fluid conduit having one directional valves to prevent back flow. Negative pressure may be applied by reducing pressure in a reservoir, and a vent may be present to release pressure when desired, e.g., FIG. 28 .

Reservoir

The breast pump system (1) and/or the milk distribution system (28) may include a reservoir (3), e.g., as shown in FIG. 15 . The reservoir (3) is a collection container for the milk, such as a bottle or bag. The reservoir (3) may be polymeric or fabric. The reservoir (3) may be in fluidic communication with the negative pressure source (9), such that fluid is moved from the breast, through the negative pressure source (9), to the reservoir (3). The reservoir (3) may be releasably connected to a fluid conduit (5), such as a tube. The reservoir (3) may be configured for ease of cleaning. The reservoir (3) may be placed in a dishwasher, refrigerator, and/or freezer. In some embodiments, the reservoir (3) is insulated, e.g., with foam or a reflective material. Typically, reservoirs (3) are removable from the system, e.g., to feed an infant.

In some embodiments, the reservoir includes a volume from about 50 mL to about 1500 mL (e.g., about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 50 mL to about 200 mL, about 50 mL to about 250 mL, about 50 mL to about 300 mL, about 50 mL to about 400 mL, about 50 mL to about 500 mL, about 50 mL to about 600 mL, about 50 mL to about 700 mL, about 50 mL to about 700 mL, about 50 mL to about 750 mL, about 50 mL to about 800 mL, about 50 mL to about 900 mL, about 50 mL to about 1000 mL, about 50 mL to about 1100 mL, about 50 mL to about 1200 mL, about 50 mL to about 1300 mL, about 50 mL to about 1400 mL, about 100 mL to about 250 mL, about 100 mL to about 500 mL, about 100 mL to about 750 mL, about 100 mL to about 1000 mL, about 100 mL to about 1250 mL, about 250 mL to about 500 mL, about 250 mL to about 750 mL, about 250 mL to about 1000 mL, about 250 mL to about 1250 mL, about 250 mL to about 1500 mL, about 500 mL to about 750 mL, about 500 mL to about 1000 mL, about 500 mL to about 1250 mL, about 500 mL to about 1500 mL, about 750 mL to about 1000 mL, about 750 mL to about 1250 mL, about 750 mL to about 1500 mL, about 1000 mL to about 1250 mL, about 1250 mL to about 1500 mL, about 50 mL, about 100 mL to about 150 mL, about 200 mL, about 250 mL, about 300 mL, about 350 mL, about 400 mL, about 450 mL, about 500 mL, about 55 mL, about 600 mL, about 650 mL, about 700 mL, about 750 mL, about 800 mL, about 850 mL, about 900 mL, about 950 mL, about 1000 mL, about 1050 mL, about 1100 mL, about 1150 mL, about 1200 mL, about 1250 mL, about 1300 mL, about 1350 mL, about 1400 mL, about 1450 mL, or about 1500 mL).

In some embodiments, the breast pump system (1) and/or the milk distribution system (28) includes a plurality of reservoirs (3). In some embodiments, breast pump system includes from 1 to 10 reservoirs (3) (e.g., from 1 to 2, from 1 to 3, from 1 to 4, from 1 to 5, from 1 to 6, from 1 to 7, from 1 to 8, from 1 to 9, from 2 to 3, from 2 to 4, from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 3 to 4, from 3 to 5, from 3 to 6, from 4 to 5, from 4 to 6, from 4 to 8, from 4 to 10, from 5 to 8, from 5 to 10, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10). In some embodiments, the breast milk distribution system (28) further includes from 2 to 12 reservoirs (3). In some embodiments, the breast milk distribution system (28) further includes from 4 to 6 reservoirs (3). In some embodiments, the plurality of reservoirs (3) is configured to be in fluidic communication with the milk chamber (21).

In some embodiments, each reservoir (3) includes a lid, wherein lid includes the pressure outlet, the inlet of the reservoir (3), and/or the valve of the reservoir (3). The lid can be integral to or attached to the reservoir (3). In some embodiments, the lid is releasably attached to the reservoir (3). In some embodiments, the lid is screwed or snapped onto the reservoir (3). In particular, the reservoir (3) may include external threads, the lid may include internal threads, and the internal threads and the external threads may provide releasable attachment of the reservoir (3) and lid. In some embodiments, the lid is attached with a magnet, e.g., an electromagnet. In some embodiments, the lid is configured to be opened and/or closed with the electromagnet. In some embodiment, the lid is configured to be opened and/or closed with pressure, e.g., air pressure.

The lid of the reservoir can have a substantially flat or rounded top surface.

In some embodiments, the reservoir (3), e.g., the lid of the reservoir (3), includes a pressure outlet. The pressure outlet may or may not include a valve (24). In some embodiments, the pressure outlet is a breather tube. In some embodiments, the pressure outlet is an orifice, e.g., the reservoir (3) or the lid of the reservoir (3) may include an orifice. In some embodiments, the milk distribution system (28) includes a pressure outlet in fluidic communication with each reservoir (3). A pressure outlet is advantageous in allowing excess pressure to vent as the reservoir (3) is being filled with milk. In some embodiments, the pressure outlet is solely open as the reservoir (3) is being filled, and the pressure outlet is otherwise nominally closed. An outlet may be connected to a negative pressure source and a vent, e.g., to remove warm air to aid in cooling or to provide suction for milk flow.

Manifold

The breast pump system (1) and/or the milk distribution system (28) can include a manifold. The manifold may include at least one inlet and at least one outlet. The manifold may also include at least one valve. In some embodiments, the manifold is disposed in the pump housing (7). In other embodiments, the manifold is in a separate enclosure.

In some embodiments, the manifold is disposed between the milk chamber (21) and a plurality of reservoirs (3). In some embodiments, the manifold is disposed between two milk chambers (21) of two breast cups (2) and the plurality of reservoirs (3). Milk from different breast pumping sessions may be directed to different reservoirs (3), such as different breast pumping sessions in the same evening. In some embodiments, each reservoir (3) includes an inlet, wherein each inlet of the reservoir in fluidic communication with a different outlet of the manifold (29). In some embodiments, the inlet of the reservoir (3) is configured to open and close. Switching from a first, second, third, fourth, fifth, etc., reservoir can be manual or automatic.

In some embodiments, the manifold includes a substrate having a plurality of fluid conduits disposed therein. In some embodiments, the manifold includes a straight manifold, a right-angle manifold, a round manifold, a block manifold, a square manifold, a hex manifold, a wye manifold, or a rotating joint manifold. In some embodiments, the manifold includes a straight manifold or a right-angle manifold. In a straight manifold, fluid enters and exits the manifold in the same direction. In a right-angle manifold, fluid exits the manifold at a right angle from the direction the fluid entered the manifold.

In some embodiments, the manifold includes an inlet. In some embodiments, the manifold includes from 1 to 20 inlets (e.g., from 1 to 2, from 1 to 3, from 1 to 4, from 1 to 5, from 1 to 6, from 1 to 7, from 1 to 8, from 1 to 9, from 1 to 10, from 1 to 15, from 2 to 3, from 2 to 4, from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 3 to 4, from 3 to 5, from 3 to 6, from 3 to 7, from 3 to 8, from 4 to 5, from 4 to 6, from 4 to 8, from 4 to 10, from 5 to 6, from 5 to 7, from 5 to 8, from 5 to 10, from 6 to 8, from 6 to 10, from 6 to 12, from 8 to 10, from 8 to 12, from 10 to 12, from 10 to 15, from 10 to 20, from 12 to 16, from 15 to 20, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20).

In some embodiments, the inlet is threaded. In some embodiments, the inlet includes internal threads and/or external threads. In some embodiments, the inlet includes a fluidic fitting. In some embodiments, the inlet includes a Luer fitting, wherein the Luer fitting may releasably connect the inlet and a fluid conduit (5).

In some embodiments, the manifold includes an outlet. In some embodiments, the manifold includes from 1 to 20 outlets (e.g., from 1 to 2, from 1 to 3, from 1 to 4, from 1 to 5, from 1 to 6, from 1 to 7, from 1 to 8, from 1 to 9, from 1 to 10, from 1 to 15, from 2 to 3, from 2 to 4, from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 3 to 4, from 3 to 5, from 3 to 6, from 3 to 7, from 3 to 8, from 4 to 5, from 4 to 6, from 4 to 8, from 4 to 10, from 5 to 6, from 5 to 7, from 5 to 8, from 5 to 10, from 6 to 8, from 6 to 10, from 6 to 12, from 8 to 10, from 8 to 12, from 10 to 12, from 10 to 15, from 10 to 20, from 12 to 16, from 15 to 20, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20). In some embodiments, the milk distribution system (28) further includes a plurality of reservoirs (3), wherein each of the plurality of reservoirs (3) is configured to be in fluidic communication with a different outlet (31) of the manifold (29). In some embodiments, the outlet is threaded. In some embodiments, the outlet includes internal threads and/or external threads. In some embodiments, the outlet includes a Luer lock connection, wherein the Luer lock connection may releasably connect the outlet and a fluid conduit (5). The outlet may include an O-ring or other gasket to seal to an inlet of a reservoir.

In some embodiments, one inlet branches into from 2 to 20 outlets (e.g., from 2 to 3, from 2 to 4, from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 3 to 4, from 3 to 5, from 3 to 6, from 3 to 7, from 3 to 8, from 4 to 5, from 4 to 6, from 4 to 8, from 4 to 10, from 5 to 6, from 5 to 7, from 5 to 8, from 5 to 10, from 6 to 8, from 6 to 10, from 6 to 12, from 8 to 10, from 8 to 12, from 10 to 12, from 10 to 15, from 10 to 20, from 12 to 16, or from 15 to 20, or 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20).

In some embodiments, the manifold includes at least one valve. In some embodiments, at least one inlet includes a valve. In some embodiments, at least one outlet includes a valve. In some embodiments, each outlet includes a valve. In some embodiments, the valve includes a ball valve, a batch dispensing valve, a butterfly valve, a diaphragm valve, a diverting valve, a gate valve, a pinch valve, a piston valve, a plug valve, a saddle valve, a solenoid valve, a stem valve, or a stop cock valve. In some embodiments, the valve includes at least one inlet and at least one outlet.

In some embodiments, the outlet of the valve is configured to move between a plurality of the outlets of the manifold. In some embodiments, the valve is a ball valve. In some embodiments, the ball of the ball valve includes at least one inlet and at least one outlet. In some embodiments, the ball may rotate to provide fluidic communication between outlet of the ball and a first outlet of the manifold and/or a second outlet of the manifold.

In some embodiments, the valve includes a solenoid valve. In some embodiments, each outlet of the manifold includes a solenoid valve. The breast pump system (1) and/or the milk distribution system (28) can include a drive unit configured to open and close the solenoid valve. In some embodiments, the solenoid valve includes a drive unit configured to open and close the solenoid valve. In some embodiments, the solenoid valve is a pinch valve.

In some embodiments, the breast milk distribution system (28) includes a drive unit (11) configured to open and close the valve (24). In some embodiments, the drive unit (11) is a stepper motor or a linear actuator. In some embodiments, the linear actuator is an electric linear actuator, a hydraulic linear actuator, or a pneumatic linear actuator. In some embodiments, the stepper motor (39) is attached to the manifold, wherein the stepper motor is configured to rotate the manifold (29).

The manifold (29) can be a rotary manifold, in which a plurality of outlets (31) is oriented circumferentially so as to line up with a plurality of reservoirs (3), wherein the manifold is configured to rotate and provide fluidic communication between the inlet (30) and each outlet (31) in sequence.

In some embodiments, the manifold (29) includes a moving, e.g., rotating, member and a stationary member. Each of the moving, e.g., rotating, member and stationary member can include a first end, a second end, and a body disposed therebetween. In some embodiments, each of the moving, e.g., rotating, member and stationary member include a first surface at the first end, and second surface at the second end. In some embodiments, the moving, e.g., rotating, member and/or the stationary member may include a channel disposed therein to transport milk and/or air. The body of each of the moving, e.g., rotating, member and/or the stationary member can have an outer surface.

In some embodiments, the moving, e.g., rotating, member is disposed within the stationary member. Alternatively, in some embodiments, the moving, e.g., rotating, member is disposed outside the stationary member.

In some embodiments, the moving, e.g., rotating, member and/or the stationary member includes an inlet (30) to the manifold (29). In some embodiments, the inlet (30) of the manifold is disposed on the first surface, second surface, or outer surface of the moving, e.g., rotating, member and/or the stationary member. In some embodiments, the moving, e.g., rotating, member and/or the stationary member includes at least one outlet (31) of the manifold (29). In some embodiments, at least one outlet (31) of the manifold is disposed on the first surface, second surface, or outer surface of the moving, e.g., rotating, member and/or the stationary member. In some embodiments, the outlets (31) of the manifold are axially or concentrically disposed in the outer surface of the moving, e.g., rotating, member or the stationary member. In some embodiments, the inlet (30) of the manifold (29) includes a longitudinal axis orthogonally arranged to a longitudinal axis of at least one of the outlets (31) of the manifold (29). In some embodiments, the inlet 30) of the manifold (29) includes a longitudinal axis orthogonally arranged to a longitudinal axis of each of the outlets (31) of the manifold (29).

In some embodiments, the moving, e.g., rotating, member and/or the stationary member include a fluid conduit (5) disposed therein, e.g., within the body. In some embodiments, the fluid conduit (5) is disposed in the body of the moving, e.g., rotating, member and/or the stationary member to provide fluidic communication between an inlet (30) of the manifold (29) and an outlet (31) of the manifold (29). In some embodiments, the fluid conduit (5) includes an outlet, and wherein the diameter of the outlet of the fluid conduit (5) includes the same diameter as the outlets (31) of the manifold (29). In alternative embodiments, the diameter of the outlet of the fluid conduit (5) is larger than the diameter of the outlets (31) of the manifold (29). In still other embodiments, the diameter of the outlet of the fluid conduit (5) is smaller than the diameter of the outlets (31) of the manifold (29). In some embodiments, the moving, e.g., rotating, member is configured to rotate and provide fluidic communication between the outlet of the fluid conduit (5) and the outlet (31) of the manifold (29), thus providing fluidic communication between the inlet (30) of the manifold and that outlet (31) of the manifold (29). In such an embodiment, the inlet (30) of the manifold (29) may or may not be in fluidic communication with other outlets (31) of the manifold.

In some embodiments, the manifold (29) includes (i) a moving, e.g., rotating, member including the inlet (30) of the manifold (29) and a fluid conduit, wherein the inlet (30) of the manifold (29) and the fluid conduit are in fluidic communication, and (ii) a stationary member including the plurality of outlets of the manifold (29); wherein the moving, e.g., rotating, member is configured to rotate and align the fluid conduit (5) with each of the plurality of outlets (31) of the manifold (29). In some embodiments, the moving, e.g., rotating, member is axially or concentrically arranged within the stationary member. In some embodiments, the outlets of the manifold (29) are radially disposed in the stationary member.

In some embodiments, the milk distribution system (28) includes a breast cup (2) configured to receive a nipple; and a manifold (29) in fluidic communication with the breast cup (2), wherein the manifold (29) includes an inlet (30) and an outlet (31) configured to move from a first position to a second position. In some embodiments, each of the plurality of reservoirs (3) are configured to be in fluidic communication with the outlet of the manifold. In some embodiments, the outlet (31) of the manifold (29) is configured to be in fluidic communication with one reservoir at a time. In some embodiments, the milk distribution system (28) further includes a drive unit (11) configured to move the outlet (31). In some embodiments, the drive unit (11) is a stepper motor or a linear actuator. In some embodiments, the linear actuator is an electric linear actuator, a hydraulic linear actuator, or a pneumatic linear actuator. In some embodiments, the manifold (29) includes the stepper motor, and wherein the stepper motor is configured to radially move the outlet of the manifold (29).

In some embodiments, the manifold (29) includes an arm having the outlet (31) of the manifold, wherein the arm is configured to rotate and provide fluidic communication between the outlet (31) and each reservoir (3) individually. Thus, in some embodiments, the breast milk distribution system (28) further includes an arm, wherein the fluid conduit is disposed in and/or on the arm. In some embodiments, the arm includes an articulating arm. In some embodiments, the arm is hollow, and the fluid conduit (5) is disposed inside the arm. In some embodiments, the fluid conduit (5) is releasably connected to the arm.

In some embodiments, the manifold includes a stationary portion with two or more arms, e.g., four. Each arm has a channel connecting an inlet (30) and an outlet (31), which is configured to be in fluidic communication with a reservoir (3). For example, the outlets may have an O-ring or other seal to seal to the reservoirs. The arms may include a top plate and a bottom plate that are sealed with a gasket (36). The manifold may also include an alignment plate (33) that has an inlet. The alignment plate can be moved, e.g., rotated, to align its inlet with that of one of the arms of the manifold. The alignment plate inlet is in fluidic communication with a fluidic conduit from a breast cup. The manifold may include a motor (39), e.g., a stepper motor, with associated drive dog (37) to mate with the alignment plate, and a vertical body (35) to move the alignment plate and support the arms. The manifold may further include a weighing plate (34) comprising a weight sensor, e.g., a scale, and a stationary base (38) disposed at the bottom of the manifold. The reservoir (3) may rest on top of the weighing plate.

Reservoir Enclosure

The breast pump system (1) and/or the milk distribution system may include a reservoir enclosure (4). The reservoir (3) may be within a reservoir enclosure (4), e.g., as shown in FIG. 15 . In some embodiments, a plurality of reservoirs (3) is disposed in an enclosure (4). The manifold may be within the enclosure.

The enclosure (4) is advantageous in that milk may be stored for a prolonged period of time, e.g., at least 10 minutes, at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 40 minutes, at least 45 minutes, at least 60 minutes, at least 1.5 hours, at least 2 hours, at least 3 hours, at least 4 hours, at least 5 hours, at least 6 hours, at least 7 hours, at least 8 hours, at least 9 hours, or at least 10 hours.

The enclosure (4) may allow the milk to safely cool for prolonged storage. In some embodiments, the enclosure (4) may maintain the milk below about 6° C. (e.g., about 5° C., about 5.5° C., about 4.5° C., about 4° C., about 3.5° C., about 3° C., about 2.5° C., about 2° C., about 1.5° C., about 1° C., about 0.5° C., or about 0° C.) for a prolonged period of time (e.g., at least 10 minutes, at least 15 minutes, at least 20 minutes, at least 30 minutes, at least 40 minutes, at least 45 minutes, at least 60 minutes, at least 1.5 hours, at least 2 hours, at least 3 hours, at least 4 hours, at least 5 hours, at least 6 hours, at least 7 hours, at least 8 hours, at least 9 hours, or at least 10 hours).

In some embodiments, the enclosure (4) includes a cooling element. The cooling element may be an ice pack and may also include insulation or heat resistant material. In some embodiments, the enclosure (4) includes a plurality of ice packs, such as from 2 to 20 (e.g., 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7, 2 to 8, 2 to 9, 2 to 10, 2 to 11, 2 to 12, 3 to 4, 3 to 5,3 to 6, 2 to 8, 3 to 10, 4 to 5, from 4 to 6, 4 to 8, 4 to 10, 4 to 12, 5 to 10, 6 to 8, 6 to 10, 6 to 12, 8 to 10, 8 to 12, 10 to 12, 10 to 20, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20). The ice pack may be stored in a freezer and then placed in the enclosure before the initiation of breast pumping.

In some embodiments, the cooling element substantially surrounds the reservoir (3). In some embodiments, the cooling element, e.g., the ice pack, is in contact with at least about 5% of the reservoir (3) (e.g., about 10%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 60%, about 70%, about 75%, about 80%, about 90%, or about 95%). In some embodiments, the cooling element conforms to the reservoir (3). In some embodiments, the cooling element is deformable ice pack.

In some embodiments, the enclosure (4) includes an internal recess, in which the reservoir (3) is configured to be placed in the recess. In some embodiments, following placement in the recess, the outer surface of the reservoir (3) is in contact with an internal surface of the recess. In some embodiments, at least about 5% (e.g., about 10%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 60%, about 70%, about 75%, about 80%, about 90%, or about 95%) of the outer surface of the reservoir (3) is in contact with the inner surface of the recess.

In some embodiments, the enclosure (4) includes a releasably attached tray, in which the tray includes a plurality of recesses (e.g., 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7, 2 to 8, 2 to 9, 2 to 10, 2 to 11, 2 to 12, 3 to 4, 3 to 5, 3 to 6, 2 to 8, 3 to 10, 4 to 5, from 4 to 6, 4 to 8, 4 to 10, 4 to 12, 5 to 10, 6 to 8, 6 to 10, 6 to 12, 8 to 10, 8 to 12, 10 to 12, 10 to 20, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20). In some embodiments, the tray includes the cooling element. In some embodiments, the tray includes an ice pack. In some embodiments, the tray is substantially formed from an ice pack.

In some embodiments, the reservoir (3) includes a recess. In some embodiments, the cooling element, e.g., the ice pack, is configured to be placed in the recess. In some embodiments, at least about 5% (e.g., about 10%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 60%, about 70%, about 75%, about 80%, about 90%, or about 95%) of the outer surface of the cooling element is in contact with the inner surface of the recess.

In some embodiments, the enclosure (4) is a cooler, e.g., as shown in FIG. 15 . In some embodiments, the enclosure (4) is electrically connected to a power source (12). In some embodiments, the enclosure (4) includes a refrigerant, e.g., a thermoelectric cooler. The reservoir enclosure may also include a thermostat to regulate the temperature.

In some embodiments, the enclosure includes a load cell or weight sensor, e.g., a scale. In some embodiments, the weight sensor may be disposed underneath the reservoir (3), such that the weight of the reservoir (3) is measured. In some embodiments, the weight of the reservoir (3) is measured over time using the weight sensor or load cell. In some embodiments, the weight of the reservoir (3) over time may be used to calculate flow rate of milk during a pumping session. In some embodiments, the weight of the reservoir (3) may be used to determine the volume of milk in the reservoir (3), the identity of reservoirs (3) filled or empty, or when a pumping cycle is complete.

In some embodiments, the enclosure further includes the pressure source.

In some embodiments, the enclosure (4) includes a lid. Various elements described herein may be disposed in the lid of the enclosure (4), including a pressure source (32), a drive unit (11), and the manifold (29).

In some embodiments, closure of the lid is configured to provide fluidic communication between at least one reservoir and at least one outlet of the manifold. For example, when the lid of the enclosure (4) is open, the reservoirs (3) may not be in fluidic communication with the manifold (29), but upon closure of the lid of the enclosure (4), at least one of the reservoirs (3) may then be placed in fluidic communication with the manifold (29).

Furthermore, the enclosure (4) may also include a pillow, such that the user may use the enclosure (4) as a pillow while resting or sleeping. In some embodiments, the reservoir (3) and/or enclosure (4) includes padding, cushioning, or stuffing. In some embodiments, the enclosure (4) includes a shape which encourages stillness during rest and/or sleep, e.g., head and/or neck support.

Alternatively, the reservoir (3) or enclosure (4) may be wearable, such as including at least one fastener, e.g., a clip and/or strap, to secure the reservoir (3) or enclosure (4) to the user, e.g., the waist of a user. While the present system is advantageous in that it may be used to breast pump while resting or sleeping, the system may also be used while going about daily activities, such as working, caring for an infant, etc.

Drive Unit and Control Unit

The breast pump system (1) and/or the milk distribution system (28) may include a drive unit (11), e.g., as shown in FIG. 10 . The drive unit (11) provides power to the elements of the breast pump system (1).

In some embodiments, the drive unit (11) is a stepper motor or a linear actuator. In some embodiments, the linear actuator is an electric linear actuator, a hydraulic linear actuator, or a pneumatic linear actuator. In some embodiments, the drive unit is a stepper motor.

The drive unit (11) may be electrically connected to the pressure source (e.g., the negative pressure source (9) or the positive pressure source) and the control valve (10).

The milk distribution system can include a drive unit (11), e.g., one configured to move at least one reservoir (3) or the manifold (29). In some embodiments, the stepper motor (39) is attached to the manifold (29), and the stepper motor is configured to move the manifold (29), e.g., the moving, e.g., rotating, member of the manifold (29).

In some embodiments, the breast pump system (1) and/or the milk distribution system (28) may include a control unit. The drive unit (11) may include a control unit. The control unit provides instructions to the drive unit (11), e.g., pre-programmed instructions or instructions provided by an external computer. The pre-programmed instructions or instructions provided by an external computer may be pumping instructions, heating instructions, cooling instructions, manifold instructions, time instructions, etc. For example, the control unit can be configured to (i) send a signal to the valve (24) to open and close or (ii) send a signal to the drive unit (11) to move the movable, e.g., rotating, member.

Fluid Conduit

The breast pump system (1) and/or the milk distribution system may include at least one fluid conduit (5), e.g., as shown in FIG. 1 , to provide movement of milk and other fluids, e.g., air.

The fluid conduits (5) may include tubing. The fluid conduit (5) may include a food contact substance. The fluid conduit (5) may include an infant grade material. The fluid conduit (5) may include polyacetal, polyoxymethylene (POM), chlorinated polyvinyl chloride (CPVC), ethylene tetrafluoroethylene (ETFE), ethylene-vinyl acetate (EVA), fluorinated ethylene propylene (FEP), nylon, polyether ether ketone (PEEK), perfluoroalkoxy alkane (PFA), PC, polyethylene, PP, PTFE (e.g., Teflon), PVC, PVDF, thermoplastic elastomer (TPE), fluorosilicone, gum, latex, neoprene, polyurethane, rubber, rubber particles encapsulated in a PP matrix (e.g., Santoprene), or silicon. In some embodiments, the breast pump system (1) includes an infant grade material.

In some embodiments, the fluid conduit (5) includes an internal diameter (ID) from about 0.5 mm to about 50 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 3 mm, about 0.5 mm to about 3.5 mm, about 0.5 mm to about 4 mm, about 0.5 mm to about 4.5 mm, about 0.5 mm to about 5 mm, about 0.5 mm to about 5.5 mm, about 0.5 mm to about 6 mm, about 0.5 mm to about 6.5 mm, about 0.5 mm to about 7 mm, about 0.5 mm to about 7.5 mm, about 0.5 mm to about 10 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, about 1 mm to about 3 mm, about 1 mm to about 3.5 mm, about 1 mm to about 4 mm, about 1 mm to about 4.5 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 25 mm, about 1 mm to about 30 mm, about 1 mm to about 40 mm, about 2 mm to about 2.5 mm, about 2 mm to about 3 mm, about 2 mm to about 3.5 mm, about 2 mm to about 4 mm, about 2 mm to about 4.5 mm, about 2 mm to about 5 mm, about 3 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 8 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 25 mm, about 5 mm to about 50 mm, about 10 mm to about 25 mm, about 20 mm to about 30 mm, about 25 mm to about 50 mm, about 30 mm to about 40 mm, about 30 mm to about 50 mm, or about 40 mm to about 50 mm).

In some embodiments, the fluid conduit (5) includes an outer diameter (OD) from about 0.5 mm to about 50 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 3 mm, about 0.5 mm to about 3.5 mm, about 0.5 mm to about 4 mm, about 0.5 mm to about 4.5 mm, about 0.5 mm to about 5 mm, about 0.5 mm to about 5.5 mm, about 0.5 mm to about 6 mm, about 0.5 mm to about 6.5 mm, about 0.5 mm to about 7 mm, about 0.5 mm to about 7.5 mm, about 0.5 mm to about 10 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, about 1 mm to about 3 mm, about 1 mm to about 3.5 mm, about 1 mm to about 4 mm, about 1 mm to about 4.5 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 25 mm, about 1 mm to about 30 mm, about 1 mm to about 40 mm, about 2 mm to about 2.5 mm, about 2 mm to about 3 mm, about 2 mm to about 3.5 mm, about 2 mm to about 4 mm, about 2 mm to about 4.5 mm, about 2 mm to about 5 mm, about 3 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 8 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 25 mm, about 5 mm to about 50 mm, about 10 mm to about 25 mm, about 20 mm to about 30 mm, about 25 mm to about 50 mm, about 30 mm to about 40 mm, about 30 mm to about 50 mm, or about 40 mm to about 50 mm).

The breast pump system (1) may be configured such that the user may roll during rest and/or sleep. Currently available breast pump systems are not designed to be utilized while resting, reclining, or sleeping.

The fluid conduit (5) may be selected to have a desired durometer to provide the preferred amount of flexibility for allowance of movement. For example, the fluid conduit (5) may have a durometer from about 25 Shore A scale and about 100 Shore D scale, including 25A, 30A, 35A, 40A, 45A, 50A, 55A, 60A, 65A, 70A, 75A, 80A, 85A, 90A, 95A, 100A, 10D, 25D, 30D, 35D, 40D, 45D, 50D, 55D, 60D, 65D, 70D, 75D, 80D, 85D, 90D, 95D, 100D, or any durometer therebetween.

The fluid conduit (5) may be configured for ease of cleaning. For example, the breast pump system (1) may be run through with water to clean the fluid conduit (5).

In some embodiments, the fluid conduit (5) may be disposed in the center of the breast cup (2), e.g., in line with a nipple. In some embodiments, the fluid conduit (5) may be disposed at the base of breast cup (2), such that milk is expressed to the side. In some embodiments, the fluid conduit (5) may be disposed at the side of the breast cup (2).

The breast pump system (1) may include any number of fluid conduits (5), e.g., one, two, three, four, five, six, seven, eight, nine, ten, etc. A portion of fluid conduits (5) may provide air flow to the breast pump system (1), while other fluid conduits (5) transport milk.

In some embodiments, the breast pump system (1) includes a first fluid conduit (5) providing fluidic communication between the milk chamber (21) and the reservoir (3). In some embodiments, the breast pump system (1) includes a second fluid (5) conduit providing fluidic communication between the pressure source and the breast cup (2). In particular, in some embodiments, a second fluid conduit (5) provides fluidic communication between (a) the negative pressure source (9) and/or the positive pressure source and (b) the pressure chamber (20).

In some embodiments, the breast pump system (1) includes a first fluid conduit (5) providing fluidic communication between the breast cup (2), the negative pressure source (9), and/or the positive pressure source. In some embodiments, the first fluid conduit is releasably connected to the breast cup (2) and/or negative pressure source (9). The breast pump system (1) may include a second fluid conduit (5) providing fluidic communication between the negative pressure source (9) and the reservoir (3). In some embodiments, the second fluid conduit (5) is releasably connected to the negative pressure source (9) and/or reservoir (3). The breast pump system (1) may include a third fluid conduit (5) providing fluidic communication between the control valve (10) and the first fluid conduit (5). In some embodiments, the third fluid conduit (5) is releasably connected to the control valve (10) and/or first fluid conduit (5).

Additional fluid conduits (5) may transport milk from a second breast. In some embodiments, a first breast cup (2) is connected to a first fluid conduit (5), and a second breast cup (2) is connected to a second fluid conduit (5). In some embodiments, the first fluid conduit (5) and the second fluid conduit (5) merge into a third fluid conduit (5). In some embodiments, the third fluid conduit (5) connects to the manifold (29). Similarly, additional fluid conduits may connect a second breast cup (2) to the pressure source (32). These fluid conduits may also merge into a single conduit that connects to the pressure source.

In some embodiments, additional fluid conduits (5) may transport milk to additional reservoirs (3). In some embodiments, the milk from different breast pumping sessions is transported to the first reservoir (3) and/or second reservoir (3) through a fluid conduit (5). The milk transported to the first reservoir (3) and/or second reservoir (3) may be transported with the same or different fluid conduit (5), e.g., a first fluid conduit (5) and a second fluid conduit (5).

In some embodiments, the milk distribution system (28) includes a fluid conduit (5) providing fluidic communication between the breast cup (2) and the inlet (30) of the manifold (29). In some embodiments, the milk distribution system (28) further includes a fluid conduit (5) providing fluidic communication between the inlet of the manifold (30) and the outlet of the manifold (31). In some embodiments, the milk distribution system further includes a plurality of fluid conduits (5) providing fluidic communication between each of the outlets (31) of the manifold (29) and the plurality of reservoirs (3).

To facilitate better movement, the breast cup (2) and fluid conduits (5) may move with the user.

Independent movement of the breast cup (2) and fluid conduits (5) allow the user to have a better range of motion, and further when the user moves the breast cup (2) does not experience force that might remove it from the breast during pumping. In some embodiments, the breast cup (2) includes a movement element. The movement element may be positioned at the nipple tunnel of the breast cup (2). In some embodiments, the first fluid conduit (5) is movably connected to the breast cup (2). In some embodiments, the first fluid conduit (5) is rotatable with respect to breast cup (2). In some embodiments, the first fluid conduit (5) is movably connected to the milk chamber (21). The movement element may be a swivel fitting or a rotating fitting. In some embodiments, the movement element includes a ball bearing.

The movement element may allow the fluid conduit (5) to rotate around the breast cup (2) from about 0° to about 360°, e.g., from about 0° to about 30°, from about 0° to about 60°, about 0° to about 90°, about 0° to about 120°, about 0° to about 150°, about 0° to about 180°, about 0° to about 210°, about 0° to about 240°, about 0° to about 300°, about 30° to about 120°, about 30° to about 180°, about 30° to about 240°, about 30° to about 360°, about 60° to about 120°, about 60° to about 180°, about 60° to about 240°, about 60° to about 360°, about 90° to about 180°, about 90° to about 360°, about 120° to about 240°, about 120° to about 360°, about 150° to about 240°, about 150° to about 360°, about 180° to about 240°, about 180° to about 360°, about 210° to about 360°, about 240° to about 360°, about 270° to about 360°, or about 300° to about 360°.

The movement element may allow the fluid conduit (5) to pivot from the center of the breast cup (2) from about 0° to about 90°, e.g., from about 0° to about 5°, about 0° to about 10°, about 0° to about 15°, about 0° to about 20°, about 0° to about 25°, about 0° to about 30°, about 0° to about 45°, about 0° to about 60°, about 0° to about 75°, about 5° to about 10°, about 5° to about 15°, about 5° to about 20°, about 5° to about 25°, about 5° to about 30°, about 5° to about 45°, about 5° to about 60°, about 5° to about 90°, about 10° to about 15°, about 10° to about 30°, about 10° to about 45°, about 10° to about 60°, about 10° to about 90°, about 30° to about 45°, about 30° to about 60°, about 30° to about 90°, about 45° to about 60°, about 45° to about 90°, or about 60° to about 90°.

A fluid conduit may have any appropriate connector at each end for connection to the breast cup (2), pump, or reservoir (3) or milk distribution system (28). Examples of connectors include Luer connectors, threaded connectors, and slip fit connectors.

Valves

The breast pump system (1) and/or the milk distribution system (28) may include one or more valves. In some embodiments, the valve is a control valve, an open-close valve, a one directional valve, a relief valve, a quick-release valve, an inflation valve, or a slow-leak valve. In some embodiments, the valve is a mechanical valve, an inflation valve, an umbrella valve, a butterfly valve, a disk valve, a non-drip valve, a duckbill valve, a ball valve, a batch dispensing valve, a diaphragm valve, a gate valve, a diverting valve, a pinch valve, a piston valve, a plug valve, a saddle valve, a solenoid valve, a stem valve, a stop cock valve, or a three-way valve.

The milk distribution system (28) can include a valve (24). Such a valve (24) is advantageous in that it can provide selective fluidic communication to a plurality of reservoirs (3), e.g., as shown in FIG. 24 . Thus, in some embodiments, the milk distribution system (28), can include a breast cup (2); a manifold (29) in fluidic communication with the breast cup (2), wherein the manifold (29) includes an inlet (30) and a plurality of outlets (31); and a valve (24) in fluidic communication with the manifold (29). In some embodiments, the breast milk distribution system (28) includes a plurality of valves (24), wherein each outlet (31) of the manifold (29) or the inlet of each reservoir (3) can include a valve (24). In some embodiments, the milk distribution system (28) is configured to close a valve (24) to a reservoir following a breast pumping session in which that reservoir (3) was filled.

The breast pump system (1) may include a control valve (10), e.g., as shown in FIG. 10 . The control valve (10) may be in fluidic communication with the breast cup (2) and the negative pressure source (9). In some embodiments, the fluid conduit (5) providing fluidic communication between the breast cup (2) and negative pressure source (9) includes the control valve (10). The control valve (10) may provide positive pressure to the breast cup (2) and/or the negative pressure source (9) in order to decrease the negative pressure provided by the negative pressure source (9), and reduce or stop milk flow, e.g., by depressurizing the nipple.

The positive pressure provided by the control valve (10) may be between 0 mmHg to 400 mmHg, e.g., about 25 mmHg. In some embodiments, the positive pressure is 0 mmHg, e.g., open atmospheric pressure. In some embodiments, the negative pressure source (9) and control valve (10) are contained within the same feature.

In some embodiments, the breast pump system (1) and/or the milk distribution system (28) may include an open-close valve. In some embodiments, the control valve includes an open-close valve. The open-close valve may be configured to open and close fluidic communication between a first element and a second element. In some embodiments, the first element can include a reservoir (3), fluid conduit (5), a pressure chamber (20), a milk chamber (21), a manifold, or the ambient atmosphere. In some embodiments, the second element can include a reservoir (3), fluid conduit (5), a pressure chamber (20), a milk chamber (21), a manifold, or the ambient atmosphere.

The breast pump system (1) may include one or more one directional valves (15) or anti-backflow valves, e.g., a plurality of one directional valves (15).

The one directional valve (15) may be a duckbill valve or other type of one directional valve.

In some embodiment, the one directional valve (15) may be placed in a fluid conduit (5), e.g., to prevent backflow of milk. In some embodiments, the one directional valve (15) is configured to allow fluid flow from the milk chamber (21) to the reservoir (3). In some embodiments, the one directional valve (15) is disposed in the first fluid conduit (5). In some embodiments, the one directional valve (15) is disposed at the outlet (22) of the milk chamber (21), e.g., FIG. 26D. In some embodiments, the one directional valve (15) is disposed in the diaphragm (18). In some embodiments, the one directional valve (15) may prevent air from entering the first fluid conduit (5), thereby maintaining negative pressure to move the milk.

In some embodiments, the one directional valve (15) is configured to allow fluid flow from the control valve (10) to the breast cup (2) or negative pressure source (9). In other embodiments, the one directional valve (15) may allow air to flow to the first fluid conduit from the control valve (10), such that the negative pressure from the negative pressure source (9) fluctuates to express milk from the breast. Thus, in some embodiments, the one directional valve (15) follows the control valve (10) in a fluid conduit (5), e.g., in the third fluid conduit (5). In some embodiments, the one directional valve (15) is between the breast cup (2) and the reservoir (3), such that milk cannot backflow from the reservoir (3). FIG. 5 shows a reservoir (3) in an enclosure (4) having a one directional valve (15).

In some embodiments, the inlet to the milk chamber (21) includes a one directional valve, e.g., as shown in FIG. 18 . In some embodiments, the one directional valve is a duckbill valve. Breast pump system (1) may further include at least one relief valve. In some embodiments, at least one fluid conduit (5) includes a relief valve. In some embodiments, the breast cup (2) includes a relief valve. If vacuum at the breast becomes too strong the relief valve may provide a release of negative pressure to prevent discomfort for the user. A relief valve may be placed such that if a predetermined maximum vacuum level is exceeded in a fluid conduit (5), such as greater than 250 mmHg vacuum (−250 mmHg pressure), the relief valve is able to provide positive pressure. The relief valve can be in the form of a spring and ball, pin and O-ring, or other equivalent mechanical means of providing pressure relief. In some embodiments, the user may activate the release valve. In some embodiments, a user may twist a relief valve to lower or shut off suction. In some embodiments, the breast pump system (1) includes one or more quick-release valves. In some embodiments, the outlet of breast cup (2), e.g., the outlet (22) of the milk chamber (21), includes a quick-release valve such that a fluid conduit (5) may be easily connected to the milk chamber (21).

In some embodiments, the breast pump system (1) includes a slow leak of pressure. The slow leak of pressure may be to the ambient atmosphere. A slow leak aids in slowly venting pressure during breast pumping. In some embodiments, the breast cup (2) includes a slow leak of pressure. In some embodiments, the breast shield (19) includes a slow leak of pressure. In some embodiments, the breast shield (19) includes an imperfect seal configured to provide a slow leak. In some embodiments, the breast shield (19) includes an orifice to provide a slow leak. In some embodiments, the slow leak includes a leak rate that would not decrease the maximum negative pressure of a pressure cycle by more than 10% (e.g., 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1%). In some embodiments, the slow leak provides a positive pressure to the breast cup (2) that is equivalent to the maximum applied negative pressure over a period of time from about 0.5 minutes to about 60 minutes (e.g., about 0.5 minutes to about 1 minute, about 0.5 minutes to about 5 minutes, about 0.5 minutes to about 10 minutes, about 0.5 minutes to about 15 minutes, about 0.5 minutes to about 30 minutes, about 1 minute to about 5 minutes, about 2 minutes to about 8 minutes, about 3 minutes to about 7 minutes, about 5 minutes to about 10 minutes, about 5 minutes to about 15 minutes, about 5 minutes to about 30 minutes, about 10 minutes to about 15 minutes, about 10 minutes to about 20 minutes, about 15 minutes to about 30 minutes, about 15 minutes to about 45 minutes, about 30 minutes to about 45 minutes, about 30 minutes to about 60 minutes or about 45 minutes to about 60 minutes). A slow leak valve may be configured to provide the slow leak of pressure. For example, if a maximum pressure of 100 mmHg is applied to the breast cup (2), e.g., the nipple tunnel of the breast shield (19), the slow leak may provide 10 mmHg of positive pressure every minute for 10 minutes.

In some embodiments, the breast pump system (1) includes a slow leak valve. The slow leak valve may be configured to provide a slow leak of pressure to the ambient atmosphere. In some embodiments, the slow leak valve includes a leak rate that would not decrease the maximum negative pressure of a pressure cycle by more than 10% (e.g., 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1%) when negative pressure is being applied to the breast cup (2).

Sensors

The breast pump system (1) may also include at least one sensor. At least one sensor may detect a baseline value, e.g., an initial pressure in the breast cup (2). Throughout breast pumping the sensor may continue detecting. Data are compared throughout breast pumping to the initially detected baseline. Sensors include weight sensors, load cells, temperature sensors, pressure sensors, pH sensors, flow sensors, viscosity sensors, volume sensors, etc. Sensors may be in the breast cup (2), at least one fluid conduit (5), in the pump system, in the reservoir (3), in the reservoir enclosure (4), or on an external surface of the breast pump system.

In some embodiments, the breast pump system (1) includes at least one weight sensor or load cell. In some embodiments, the weight sensor is disposed in the bottom of the reservoir (3). In some embodiments, the weight sensor is disposed in the bottom of the reservoir enclosure (4), underneath a plurality of reservoirs (3), such that the weight of the reservoirs may be measured. In some embodiments, the weight sensor is disposed with a weighing plate (34). Weight sensors may track the weight of the reservoirs (3) over time. In some embodiments, weight data may be used to determine flow rate of milk during a pumping session. In some embodiments, weight sensors may be used to determine the volume of milk inside of a reservoir (3).

In some embodiments, the breast pump system (1) includes at least one temperature sensor, e.g., a thermocouple. In some embodiments, the breast pump includes a plurality of temperature sensors. Temperature sensors may provide time history data. Using the circadian baseline, deviations from baseline may be identified. In some embodiments, the reservoir (3) includes a temperature sensor. A change in temperature of milk may indicate spoiled milk.

The breast pump system (1) may include at least one pressure sensor. In some embodiments, the breast pump includes a plurality of pressure sensors. Pressure sensors may include diaphragms, strain gauges, piezoresistive pressure sensors, capacitive pressure sensors, or electromagnetic sensors. Pressure sensors may be used to measure the pressure in the breast cup (2), e.g., in the pressure chamber (20), milk chamber (21), and/or breast shield (19). Data from the pressure sensor may be used to determine the pressure used to express milk from the nipple. Pressure sensors are also advantageous in that they may detect high pressure levels which may cause discomfort for the user. In some embodiments, the breast cup (2) includes a pressure sensor. In some embodiments, the reservoir (3) includes a pressure sensor. In some embodiments, each reservoir (3) includes a pressure sensor. A pressure sensor in a reservoir can be advantageous in determining over pressurization of the reservoir (3), e.g., as a result of milk being pumped into the reservoir (3).

The breast pump system (1) may include at least one pH sensor. In some embodiments, the breast pump includes a plurality of pH sensors. In some embodiments, the pH sensor is an ion sensitive glass electrode.

The breast pump system (1) may include at least one flow sensor. In some embodiments, the breast pump includes a plurality of flow sensors. In some embodiments, a fluid conduit (5) includes a flow sensor. A flow sensor may detect the rate of fluid flow in the fluid conduit (5).

The breast pump system (1) may include at least one volume sensor. In some embodiments, the breast pump includes a plurality of volume sensors. In some embodiments, the reservoir (3) includes a volume sensor. A volume sensor may detect the level of milk in the reservoir (3).

The breast pump system (1) may include at least one optical sensor. In some embodiments, the breast pump includes a plurality of optical sensors. The optical sensor may include a light source, e.g., an LED light source, and associated photodetector. The light source in one example emits light at different wavelengths within the visible spectrum, including a violet light, a blue light, a green light, a yellow light, an orange light and a red light. In various embodiments, the optical sensor includes a singular light source or a plurality of light sources, similarly the photodetector may include a single photodetector or a plurality of photodetectors. In some embodiments, the reservoir (3) may include an optical sensor.

In some embodiments, the optical sensor may sense movement of the breast cup (2) on the breast. Sensing the movement of the breast cup (2) on the breast is advantageous in that it may measure how much the breast cup (2) moves during use, e.g., such as through the night. In some embodiments, the breast pump system (1) can alert the user if it becomes unaligned or loose. In some embodiments, the optical sensor is in view of a portion of the skin of the user. In some embodiments, the breast cup (2), e.g., an outer surface of breast cup (2), e.g., the housing (17), includes the optical sensor. In some embodiments, the optical sensor is mounted on the housing (17).

In some embodiments, the optical sensor may sense the clarity of the milk in the reservoir (3). The clarity of the milk may be indicative of fat content, e.g., a lower clarity may be indicative of a higher fat content.

The breast pump system (1) may include at least one viscometer. In some embodiments, the breast pump system (1) includes a plurality of viscometers. In some embodiments, the reservoir (3) includes a viscometer. The viscometer may sense the viscosity of the milk, e.g., the milk in the reservoir (3).

In some embodiments, the breast pump system (1) and/or the milk distribution system (28) includes a Hall effect sensor. A Hall effect sensor is a sensor which detects the presence and magnitude of a magnetic field using the Hall effect. A Hall effect sensor is advantageous in that it may allow the breast pump system (1) and/or the milk distribution system (28) to collect information on whether the system completes actions. The information collected by the Hall effect sensor may be used to provide assurance and aid in diagnosing any errors.

Additional Elements

In some embodiments, the breast pump system (1) and/or milk distribution system (28) includes a heating system. A heating system is advantageous in that the breast cup (2) may be heated prior to or during breast pumping for improved comfort. In some embodiments, the heating system is disposed in the breast shield (19). In some embodiments, the heating system includes insulation, an insertion heater, a resistive heater, a thermoelectric heater, a heating film, a heating pad, a heating wire, or a pneumatic heating tube.

In some embodiments, the breast pump system (1) and/or the milk distribution system (28) includes a pressure outlet. The pressure outlet may or may not include a valve (24). In some embodiments, each pressure outlet includes a valve (24). In some embodiments, the pressure outlet is a breather tube. In some embodiments, the pressure outlet is an orifice, e.g., the reservoir (3) or the lid of the reservoir (3) may include an orifice. In some embodiments, the milk distribution system (28) includes a pressure outlet in fluidic communication with each reservoir (3).

In some embodiments, the reservoir (3) includes a pressure indicator, e.g., a flexible membrane. A pressure indicator, e.g., a flexible membrane, may be advantageous in indicating if there is negative or positive pressure within the reservoir (3). Negative pressure may be the result of hot milk being cooled when the reservoir (3) is closed to the ambient atmosphere and/or the milk distribution system (28).

In some embodiments, the breast pump system (1) and/or the milk distribution system (28) includes a waste reservoir. In some embodiments, following a breast pumping session, the breast pump system (1) and/or milk distribution system (28) may flush the system with a cleaning fluid, wherein the cleaning fluid is transported to a waste reservoir. In some embodiments, the cleaning fluid is water. In some embodiments, the cleaning fluid is air. In some embodiments, the breast pump system (1) and/or the milk distribution system (28) is configured to be flushed with a pressure source, e.g., positive pressure source or a negative pressure source, e.g., a vacuum pump.

In some embodiments, the breast pump system (1) and/or milk distribution system (28) may include an anti-bacterial coating, e.g., in the reservoir (3) or the fluid conduits (5).

The breast pump system (1) and/or milk distribution system (28) may include a power source (12). The power source (12) may be a battery and/or an AC power source. The power source (12) may be electrically connected to the control unit and the pumping mechanism.

The breast pump system (1) and/or milk distribution system (28) may include a display. The display may be disposed on the pump housing (7) or reservoir enclosure (4). The display may be a screen. In some embodiments, the screen is a touchscreen.

The breast pump system (1) and/or milk distribution system (28) may include a timer. The drive unit (11) and/or control unit may include the timer. The timer may be disposed in the pump housing (7) or reservoir enclosure.

The breast pump system (1) and/or milk distribution system (28) may include an alarm. The alarm may be disposed in the pump housing (7) or reservoir enclosure. The alarm may be a light, a vibration element, or a sound element. The alarm may be configured to sound in the event of an error (e.g., the pumping system is improperly assembled), the ending of a pumping session, a temperature increase in the milk in the reservoir (3), a full reservoir (3), and/or the start of an upcoming preprogrammed pumping session.

The breast pump system (1) and/or milk distribution system (28) may include a power switch (14) or button. The power switch (14) or button may enable a user to power on or off the breast pump system (1). The power switch (14) or button may be disposed on the outside of the pump housing (7). Alternatively, or in addition, the power switch (14) or button may be disposed on the breast cup (2). Alternatively, or in addition, the power switch (14) or button may be disposed on the reservoir enclosure (4). However, in some embodiments, the user may power on or off the breast pump system (1) remotely, such as through an application on an external computer, e.g., a mobile device.

Wearability

The breast pump system (1) may include a garment to secure the breast cup (2) to the user. The garment may secure the breast cup (2) in place, and/or stabilize breast cup (2) for milk expression. In some embodiments, the breast cup (2) is inserted into the garment.

The garment may be a bra, a bustier, a sports bra, a shirt, a tank top, a bandeau, a strap, a dress, a nightgown, or a nursing bra that provides support to a wearer and/or at least a portion of a breast pump system (1). In some embodiments, the garment includes polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill. In some embodiments, the garment is machine washable.

In some embodiments, the breast cup (2) is held in place by compression provided by the garment. The garment may provide a level of compression of the breast cup (2) to the breast such that the subject may move, rest, and/or sleep with the breast cup continuing to be secured to the breast. Securement of the breast cup (2) to the breast during movement improves safety and reduces milk leakage. The garment may include a flexible or stretch material, e.g., nylon, elastic, or spandex. The garment may include portions of varying compression, e.g., high compression portions and low compression portions. For example, the material of the garment contacting the breast cup may include a high compression portion. The garment may apply a compression of at least 5 mmHg, e.g., at least 10 mmHg, 15 mmHg, 20 mmHg, 25 mmHg, 30 mmHg, 35 mmHg, 40 mmHg, 45 mmHg, 50 mmHg, 55 mmHg, 60 mmHg, 65 mmHg, 70 mmHg, 75 mmHg, 80 mmHg, 85 mmHg, 90 mmHg, 95 mmHg, 100 mmHg, 125 mmHg, or 150 mmHg. In other embodiments, the garment may apply a compression from about 5 mmHg to about 100 mmHg, e.g., about 5 mmHg to about 10 mmHg, about 5 mmHg to about 15 mmHg, about 10 mmHg, to about 20 mmHg, about 5 mmHg to about 25 mmHg, about 5 mmHg to about 30 mmHg, about 5 mmHg to about 35 mmHg, about 5 mmHg to about 40 mmHg, about 5 mmHg to about 45 mmHg, about 5 mmHg to about 50 mmHg, about 5 mmHg to about 60 mmHg, about 5 mmHg to about 70 mmHg, about 5 mmHg to about 80 mmHg, about 5 mmHg to about 90 mmHg, about 5 mmHg to about 100 mmHg, about 10 mmHg to about 20 mmHg, about 10 mmHg to about 30 mmHg, about 10 mmHg to about 40 mmHg, about 10 mmHg to about 50 mmHg, about 10 mmHg to about 75 mmHg, about 10 mmHg to about 100 mmHg, about 20 mmHg to about 30 mmHg, about 20 mmHg to about 40 mmHg, about 20 mmHg to about 50 mmHg, about 25 mmHg to about 50 mmHg, about 25 mmHg to about 75 mmHg, about 25 mmHg to about 100 mmHg, about 40 mmHg to about 50 mmHg, about 40 mmHg to about 60 mmHg, about 40 mmHg to about 70 mmHg, about 40 mmHg to about 80 mmHg, about 40 mmHg to about 90 mmHg, about 40 mmHg to about 100 mmHg, about 50 mmHg to about 60 mmHg, about 50 mmHg to about 60 mmHg, about 50 mmHg to about 70 mmHg, about 50 mmHg to about 80 mmHg, about 50 mmHg to about 100 mmHg, about 60 mmHg to about 70 mmHg, about 60 mmHg to about 80 mmHg, about 60 mmHg to about 70 mmHg, about 60 mmHg to about 80 mmHg, about 60 mmHg to about 90 mmHg, about 60 mmHg to about 100 mmHg, about 70 mmHg to about 80 mmHg, about 70 mmHg to about 90 mmHg, about 70 mmHg to about 100 mmHg, about 80 mmHg to about 90 mmHg, about 80 mmHg to about 100 mmHg, or about 90 mmHg to about 100 mmHg.

The garment provides access to at least one breast to facilitate breastfeeding and/or pumping. Several embodiments are described to provide access to at least one breast. In some embodiments, the user may pull the garment away from their skin, and insert the breast cup (2) underneath the garment from below or above the garment. In some embodiments, the garment may have openings formed or defined in the material that makes up the garment to provide an opening for access to at least one of the wearer's breasts. In some embodiments, the opening in the garment has a smaller diameter than the largest diameter of the breast cup (2). In some embodiments, the breast cup (2) and/or housing (17) are inserted into at least one opening formed in the material of the garment, and compression of the material secures it to the breast. This configuration is advantageous such that the breast cup (2) may not be pulled out from the garment unintentionally. For example, the nipple tunnel (13) of the breast cup (2) may be inserted through the opening in the garment such that the wide portion (8) of the breast cup (2) may contact the garment, but not pass through. The nipple tunnel (13) of the breast cup may then be releasably connected to a fluid conduit (5).

The opening in the garment may have a diameter from about 5 mm to about 250 mm, e.g., from about 5 mm to about 10 mm, about 5 mm to about 20 mm, about 5 mm to about 25 mm, about 5 mm to about 30 mm, about 5 mm to about 40 mm, about 5 mm to about 50 mm, about 5 mm to about 75 mm, about 5 mm to about 100 mm, about 10 mm to about 20 mm, about 10 mm to about 25 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 20 mm to about 25 mm, about 20 mm to about 30 mm, about 20 mm to about 40 mm, about 20 mm to about 50 mm, about 25 mm to about 50 mm, about 25 mm to about 75 mm, about 30 mm to about 40 mm, about 30 mm to about 50 mm, about 40 mm to about 50 mm, about 50 mm to about 75 mm, about 50 mm to about 100 mm, about 50 mm to about 125 mm, about 50 mm to about 150 mm, about 50 mm to about 75 mm, about 75 mm to about 100 mm, about 75 mm to about 125 mm, about 75 mm to about 150 mm, about 75 mm to about 175 mm, about 75 mm to about 200 mm, about 100 mm to about 125 mm, about 100 mm to about 150 mm, about 100 mm to about 175 mm, about 100 mm to about 200 mm, about 125 mm to about 150 mm, about 125 mm to about 175 mm, about 125 mm to about 200 mm, about 150 mm to about 175 mm, about 150 mm to about 200 mm, about 150 mm to about 250 mm, or about 200 mm to about 250 mm. The opening may have a diameter less than 100 mm, e.g., less than 90 mm, 80 mm, 70 mm, 60 mm, 50 mm, 40 mm, 30 mm, 25 mm, 20 mm, 10 mm or 5 mm.

The garment may include at least one layer, e.g., two layers. The two layers may overlap such that they may be pulled apart to reveal at least one breast. In some embodiments, the garment includes at least two layers, and the breast cup (2) and/or housing (17) are secured to the breast by positioning between at least two layers. Alternatively, or additionally, the garment may include snaps, buttons, or a zipper which may be opened to provide access to at least one breast. In addition to providing access to at least one breast, the breast pump system (1) may include a fastener for securing the breast cup (2) and/or housing (17) to the garment. The breast pump system (1) may also include a fastener for securing the fluid conduit (5). The fastener may be used to route the fluid conduit (5) to an advantageous location (e.g., under the arm, or under the garment), such that the fluid conduit does not impede the user's freedom of motion. The breast pump system (1) may also include a fastener system for the reservoir (3) and/or reservoir enclosure (4). The fastener may attach the reservoir (3) and/or reservoir enclosure (4) to the user, such that they are able to conduct their daily activities while breast pumping. The fastener may include a clip, a strap, a hook, a zipper, a magnet, a pin, a button, a snap, a hook and loop fastener (e.g., VELCRO®), or a combination thereof. The fastener may fasten the reservoir (3) and/or reservoir enclosure (4) to the user in such a way that they may have freedom of motion, e.g., fasten the reservoir (3) and/or reservoir enclosure (4) to the waist of the user.

Securement to the breast may be further improved by negative pressure provided by the negative pressure source (9).

The breast pump system (1) may be reversibly connected to the garment before or after the garment is donned. In some embodiments, the breast cup (2) and/or housing (17) are reversibly secured to the garment and then the garment is donned. In some embodiments, the garment is donned, and then the breast cup (2) and/or housing (17) are reversibly secured to the garment. In some embodiments, the breast cup (2) and/or housing (17) are irreversibly secured to the garment. In some embodiments, the fluid conduit (5) is reversibly secured to the breast cup (2) after the garment is donned. In some embodiments, the fluid conduit (5) is reversibly secured to the breast cup (2) prior to the garment being donned.

In some embodiments, the outer surface of breast cup (2) has a lower coefficient of friction than the inner surface of the garment to allow freedom of movement. Without wishing to be bound to theory, if there is a lower coefficient of friction between the breast cup (2) and the garment than between the breast cup (2) and the breast, then relative movement of the garment is less likely to move the breast cup (2) out of position. In some embodiments, the coefficient of friction between the outer surface of the breast cup (2), e.g., the housing (17), and the garment is less than 0.4 (e.g., 0.35, 0.3, 0.25, 0.2, 0.15, 0.1, or 0.05). In some embodiments, the outer surface of the breast cup (2), e.g., the housing (17), can include a smooth material. In some embodiments, the outer surface of the breast cup (2), e.g., the housing (17), can include a smooth plastic or fabric. In some embodiments, the outer surface of the breast cup (2), e.g., the shield (17), can include PET, PP, PTFE, polyethylene, HDPE, LDPE, PC, nylon, acetal, PEEK, PPS, or polyester. In some embodiments, the outer surface of the breast cup (2), e.g., the housing (17), can include cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim or drill.

Breast Pump System and Milk Distribution System Control

The breast pump system (1) and/or the milk distribution system may include controls that are operable by a user to select or modify at least one of: pumping program or mode, frequency of pumping cycle, maximum suction pressure achieved during a pumping cycle, latch suction pressure achieved during the pumping cycle, volume of the pressure chamber (20), pumping force, pumping session time, and distribution of milk to reservoirs (3). The controls may be present on the surface of the pump housing (7) or reservoir enclosure (4), e.g., on the display. Alternatively, or in addition, the controls may be present in an application on an external computer, e.g., a mobile device. Alternatively, neither the pump housing (7) or reservoir enclosure (4) includes controls, and the breast pump system (1) is solely controlled through an application on an external computer, e.g., a mobile device. Control of the breast pump system (1) through an application on an external computer is advantageous in that a user may control the device in any position.

In some embodiments, the breast pump system (1) can have a wait time set, e.g., through the display or an application on an external computer, such that the user has time to contact the breast cup (2) to their breast before the breast pump system (1) begins pumping.

Control of the breast pump system (1) may be customized. The customized pump functions include modifications to at least one of: maximum suction pressure level, latch suction pressure level, suction pressure waveform over a pumping cycle, phases of extraction or feeding times, rest times, heating temperatures and times, vibration frequency and duration, pumping session time, and distribution of milk to reservoirs (3). The user may input at least one pump program into the breast pump system(1), e.g., through the display or application on an external computer. For example, the user may set the number of minutes that the breast pump system (1) will run before shutting off automatically and/or the user may set a time for the breast pump system (1) to engage during the night. Custom pump programming is advantageous in that user may control how long they pump for so that they may go about their daily activities, resting, or sleeping, without the worry that the pump will continue endlessly. In some embodiments, the pumping frequency may be programmed to slow down gradually during operation, e.g., towards the end of a preprogrammed pumping time.

Wireless

The control unit may be configured to send signals to and receive signals from an external computer, e.g., a mobile device.

The control unit may include a transmission element, e.g., a wireless transmission element, and receiver element for wirelessly sending signal to and receiving signals from the external computer. In some embodiments, the transmission element is a BLUETOOTH® transmission element.

The external computer may include a processor and instructions, which when executed, cause the processor to customize pump functions and send customized pump functions to the control unit. In some embodiments, the custom pump functions are based on the signals received from the control unit, such as measurements taken by sensors. In some embodiments, the user is able to program different custom pump programs, e.g., a daytime program and a nighttime program.

The external computer may include a processor and Instructions, which when executed, cause the processor to calculate volume of milk extracted and track expression efficiency and monitor it over time. In some embodiments, the calculation of milk extracted, and expression efficiency are based on signals received from the control unit, such as measurements taken by the sensors.

The external computer may include a processor and instructions, which when executed, cause the processor to transport milk from a breast pumping session to a reservoir, including transporting milk from a first breast pumping session to a first reservoir, and milk from a second breast pumping session to a second reservoir.

The external computer may include a processor and instructions, which when executed, cause the processor to track of inventory of previous pumping sessions, including tracking at least one of dates of the previous pumping sessions, volumes pumped in the previous pumping sessions, and specific tracking numbers for specific milk collection containers into which milk has been pumped in the previous pumping sessions.

The external computer may include a processor and instructions, which when executed, cause the processor to one or more of monitor remaining battery power of the battery and output a warning when the battery reaches a predetermined low level of charge.

The external computer may include a processor and instructions, which when executed, cause the processor to display in the application screen or on display of the breast pump system (1) the time left in the pumping session, measurements taken by the at least one sensor, and/or one or more photos of the user's choosing on the display.

Breast Pumping and Related Conditions

Many mothers rely on breast pumping to provide milk to their infants, stimulate lactation, or relieve engorgement. For the mothers of newborns, breastfeeding or breast pumping often occurs every two hours, interrupting daytime, and sleep schedules. Consistent breastfeeding or breast pumping, however, may contribute to a number of conditions in women, in particular due to a lack of rest. Improved breast pump systems may lessen or reduce the occurrences of these conditions, while still allowing women to breast pump consistently.

Breast Pumping

In the United States, approximately 85% of mothers with healthy newborn infants' express milk within the first four months post-birth, and the majority do so using a breast pump. Breast pumps replace the infant for purposes of milk removal and stimulation of the mammary gland, whether breast pump use is minimal (e.g., brief separations) or complete (infant does not feed at breast). Breast pumping provides the infant with adequate nourishment and the mammary gland with adequate stimulation.

Infants use a combination of suction and expression when feeding from the breast. During suction, the infant uses negative pressure to create the elongated nipple shape and transfer milk from the breast. In contrast, during expression, the infant compresses the ducts in the mammary gland, which stops or slows milk transfer, and allows the infant to safely swallow the milk and reopen their airway to breathe. Breast pumps replicate this alternating pressure in order to draw milk from a breast into a reservoir.

Nighttime Breastmilk Composition

Breast milk produced in the evening and night may contain advantageous levels of fat, hormones, and amino acids. The overall amount of fat in breast milk is highest in the evening and at night, compared with milk produced during the day. Additionally, several hormones and amino acids which aid infant sleep are highest in milk during the night, as compared with milk produced during the day. The hormone leptin, which suppresses appetite, is highest in breast milk near midnight. Melatonin and histidine levels are highest in milk produced in the night. Histidine is an amino acid, but also a precursor to histamine. Both melatonin and histamine promote sleepiness. Tryptophan, the amino acid needed to synthesize melatonin, is also highest at night. High concentrations of leptin, tryptophan, melatonin, and histidine aid nursing infants in receiving signals that minimize hunger and promote sleepiness. Thus, the ability for nursing mothers to breast pump in the night aids in the collection of milk that later helps their infants sleep.

Melatonin not only aids infant sleep but also may protect against adverse cardiovascular outcomes in the long term. Melatonin is an active molecule that is present in the breast milk produced at night beginning in the first stages of lactation. The melatonin concentration in breast milk varies in a circadian pattern, making breast milk a chrononutrient. The consumption of melatonin can induce the first circadian stimulation in the infant's body at an age when their own circadian machinery is not yet functioning. Melatonin is also a powerful antioxidant with the ability to act on infant cells directly as a scavenger, as well as indirectly, by lowering oxidant molecule production and enhancing the antioxidant capacity of the body. Melatonin also participates in regulating inflammation. Furthermore, melatonin can participate in shaping the gut microbiota composition, richness, and variation over time, also modulating which molecules are absorbed by the host. In all these ways, melatonin from breast milk influences weight gain in infants, limiting the development of obesity and comorbidities in the long term, and it can help shape the ideal cellular environment for the development of the infant's cardiovascular system. Nighttime breast pumping is able to collect milk having higher levels of beneficial melatonin, further serving infant health.

Mastitis

Mastitis is a relatively common breast condition which can affect patients at any time but predominates in women during the breastfeeding period. Mastitis is inflammation of the breast with or without infection. Approximately 3% to 33% of women suffer from mastitis while breastfeeding, particularly in the 6 months after childbirth when breastfeeding and pumping may be considered the most important. The main initiating factor of mastitis is milk stasis. Milk stasis is the buildup of milk within the breast tissue of lactating women and leads to the blockage of a milk duct within the breast or in the opening of a milk duct.

Several factors provoke milk stasis including an attempt to increase the time between breastfeeding or pumping, restricting the duration of breastfeeding or pumping, incorrect latch of the infant to the nipple, ineffective suction from the infant or pump, overproduction of milk, rapid and non-gradual weaning, pressure exerted on the breast by a bra, or nipple wound. While decreased breastfeeding and pumping may precipitate mastitis, mastitis may further prevent breastfeeding and pumping, as use of an inflamed or infected nipple is painful. Currently, there are no interventions proven effective for preventing mastitis. Optimizing breastfeeding technique will be beneficial to prevent or reduce mastitis.

As infrequent breastfeeding and pumping are correlated to mastitis, improved methods of breast pumping may alleviate symptoms of mastitis or reduce the incidence thereof.

Postpartum Depression

Postpartum depression is moderate to severe depression with onset during the first year after birth and often occurring within the first 3 months after birth. An estimated 13% to 19% of childbearing women will experience postpartum depression, making it one of the most common morbidities related to childbirth. Postpartum depression manifests as mood swings, changes in appetite, fear of injury, serious concerns about the baby, sadness, sense of doubt, difficulty in concentrating, lack of interest in daily activities, and in some cases thoughts of death and suicide.

The presence of insomnia or sleep disturbance during the perinatal period is a risk factor for depressive symptoms, including depression, anxiety, and psychosis. After pregnancy, women experience a sudden drop in levels of estrogen, progesterone, and thyroid hormones. This hormone change affects the sleep cycle. Over time, if sleep doesn't improve, the likelihood of developing postpartum depression increases. Furthermore, the relationship between sleep deprivation and postpartum depression is likely bidirectional, with depression often exacerbating sleep difficulties.

As sleep quality is correlated to postpartum depression, improved methods of breast pumping may alleviate symptoms of postpartum depression or reduce the incidence thereof.

Methods of Use

The present disclosure provides improved methods of breast pumping.

The present disclosure provides a method of breast pumping by: (i) providing a breast pump system (1) of the disclosure including: (ii) contacting a human breast with the breast cup; and (iii) applying an alternating first pressure and second pressure such that milk is moved from the human breast to the reservoir (3), in which the first pressure and the second pressure are functions of a negative pressure and a positive pressure.

In some embodiments, the breast cup (2) includes a wide portion and a nipple tunnel, and the method includes contacting the human breast with the wide portion of the breast cup (2). In some embodiments, the method includes positioning the nipple in the nipple tunnel of the breast cup (2). In some embodiments, the method includes contacting two human breasts with the two breast cups (2).

In some embodiments, the method includes applying negative pressure to the pressure chamber (20) with the negative pressure source (9). Pressure around the nipple is reduced to below atmospheric pressure.

In some embodiments, the method includes deforming the diaphragm (18) away from the breast cup. In some embodiments, the method includes deforming the diaphragm (18) away from the inlet. In some embodiments, the method includes unsealing the inlet. Deformation of the diaphragm (18) away from the inlet allows milk to flow from the nipple to the milk chamber (21). In some embodiments, the method includes expanding the milk chamber (21). In some embodiments, the method includes providing negative pressure to elongate the nipple. In some embodiments, the method includes drawing milk from the nipple. In some embodiments, the method includes drawing milk from the nipple tunnel (2) into the milk chamber (21). In some embodiments, the method includes drawing milk through the inlet.

In some embodiments, the method includes opening the control valve (10) and depressurizing the pressure chamber (20). In some embodiments, the method includes returning the diaphragm (18) to a nominal position. In some embodiments, the method includes closing the control valve (10).

In some embodiments, the method includes applying positive pressure to the pressure chamber (21) with the positive pressure source. In some embodiments, the method includes allowing the nipple to contract. In some embodiments, the method includes deforming the diaphragm (18) towards the breast shield (19). In some embodiments, the method includes allowing the diaphragm (18) to return to a nominal position. In some embodiments, the method includes sealing the inlet with the diaphragm (18). Deformation of the diaphragm (18) towards the breast shield seals the inlet such that the nipple is allowed to contract. In some embodiments, the method includes sealing the orifices with diaphragm (18). In some embodiments, the method includes contracting the milk chamber (21). Contraction of the milk chamber acts to pump milk out of the breast cup.

In some embodiments, the method includes transporting milk from the milk chamber (21) to the reservoir (3). In some embodiments, the method includes transporting milk through the first fluid conduit.

In some embodiments, the method includes transporting milk through the outlet. In some embodiments, the method includes transporting milk through the one directional valve. In some embodiments, the method includes applying pressure to the manifold (29) with a pressure source to transport milk to a reservoir (3). Thus, in some embodiments, the pressure source, or a second pressure source, can be in fluidic communication with the manifold (29). In some embodiments, a positive pressure source is in fluidic communication with the manifold (29) and transports milk to a reservoir (3). In some embodiments, the method includes applying a negative pressure source to the milk chamber (21) at the end of the pumping session. In this embodiment, the negative pressure transports any residual milk from the milk chamber (21) and fluid conduit (5) into the reservoir (3). In some embodiments, the negative pressure source is a peristaltic pump, e.g., on a first conduit or downstream component connected thereto. Positive pressure may also be introduced into the milk chamber, e.g., via a separate inlet, to aid in transport of milk or cleaning. The clearing of milk from the fluid conduit and/or milk chamber may occur only once at the end of a breast pumping cycle.

In some embodiments, the method includes providing a cleaning fluid to the breast pump system (1) and/or milk distribution system (28). In some embodiments, the method includes transporting a cleaning fluid from the breast cup (2) to a waste reservoir (3). In some embodiments, the cleaning fluid is transported through the manifold (29). In some embodiments, the cleaning fluid is water. In some embodiments, the method includes pumping milk from the human breast twice, in which there is at least 30 minutes from a first breast pumping session to a second breast pumping session. In some embodiments, the method includes pumping milk from the human breast 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times. In some embodiments, the method includes pumping milk from the human breast a plurality of times (e.g., from 2 to 3 times, from 2 to 4 times, from 2 to 5 times, from 2 to 6 times, from 2 to 10 times, from 3 to 4 times, from 3 to 5 times, from 3 to 10 times, from 4 to 5 times, from 4 to 6 times, or from 5 to 10 times). In some embodiments, the method is used to pump breast milk about 8-10 times in 24 hours. Cleaning may occur once every 24 hours, e.g., after about 8-10 pumping sessions.

In some embodiments, the time between one breast pumping session and another breast pumping session (e.g., between a first breast pumping session and a second breast pumping session, a second breast pumping session and a third breast pumping session, a third breast pumping session and a fourth breast pumping session, etc.) is from about 30 minutes to about 240 minutes (e.g., about 30 minutes to about 45 minutes, about 30 minutes to about 60 minutes, about 30 minutes to about 90 minutes, about 30 minutes to about 120 minutes, about 30 minutes to about 180 minutes, about 45 minutes to about 60 minutes, about 45 minutes to about 90 minutes, about 45 minutes to about 120 minutes, about 60 minutes to about 90 minutes, about 60 minutes to about 120 minutes, about 50 minutes to about 180 minutes, about 60 minutes to about 210 minutes, about 90 minutes to about 120 minutes, about 90 minutes to about 180 minutes, about 90 minutes to about 210 minutes, about 90 minutes to about 240 minutes, about 120 minutes to about 180 minutes, about 120 minutes to about 210 minutes, about 120 minutes to about 240 minutes, about 180 minutes to about 210 minutes, about 180 minutes to about 240 minutes, about 210 minutes to about 240 minutes, about 30 minutes, about 45 minutes, about 60 minutes, about 85 minutes, about 90 minutes, about 105 minutes, about 120 minutes, about 135 minutes, about 150 minutes, about 165 minutes, about 180 minutes, about 195 minutes, about 210 minutes, about 225 minutes, or about 240 minutes). In some embodiments, the breast pump system (1) and/or the milk distribution system (28) may enter a waiting phase between breast pumping sessions where the breast cup (2) and/or manifold (29) is not in fluidic communication with any reservoir (3). In some embodiments, following a breast pumping session, the breast pump system (1) and/or milk distribution system (28) places the breast cup (2) and/or manifold (29) in fluidic communication with a second reservoir (3). The second reservoir (3) may be empty.

In some embodiments, milk from the first breast pumping session is transported to a first reservoir, and milk from the second breast pumping session is transported to a second reservoir. Likewise, milk from a third, fourth, fifth, sixth, seventh, eighth, ninth, or tenth breast pumping session may be transported into a third, fourth, fifth, sixth, seventh, eighth, ninth, or tenth reservoir, respectively. In some embodiments, the method includes removing fluidic communication between the breast cup (2) and all of the reservoirs (3) between breast pumping sessions. In some embodiments, a plurality of valves is closed to remove fluidic communication between the breast cup (2) and all of the reservoirs (3). Once full, a reservoir may be removed and replaced with an empty reservoir.

The method may further include assembling the breast pump system (1). In some embodiments, the method includes releasably connecting at least one fluid conduit (5) to the pump housing (7), or the pump system directly. In some embodiments, the method further includes releasably connecting at least one fluid conduit to the breast cup (2). In some embodiments, the method includes releasably connecting at least one fluid conduit to the reservoir (3). In some embodiments, the method includes connecting the first fluid conduit (5) to the milk chamber (21) and the reservoir (3). In some embodiments, the method includes connecting the second fluid conduit (5) to the negative pressure source (9) and the pressure chamber (20).

Releasable connections between the breast pump system (1) are advantageous for ease of cleaning.

The breast pump system (1) is advantageous in that the user may be able to breast pump a plurality of times following a one-time assembly. Prior to the first use, the user may secure the breast cup to a breast and/or garment to their body. Then, in some embodiments, the user does not need to remove the breast cup (2) and/or garment between a plurality of breast pumping sessions, e.g., two, three, four, five, six, seven, eight, nine, or ten breast pumping sessions. The breast pump system (1) is further advantageous in that the user may be able to breast pump in a reclined position. As the breast pump system (1) may be used for an extended time, e.g., overnight, the user's ability to place the wearable component on one time, yet still use the pump several times without removal of the garment will allow for uninterrupted sleep during at least one breast pumping session. A pre-programmed pumping schedule may initiate the breast pump system (1) at least once, e.g., two, three, four, five, six, seven, eight, nine, ten times, etc. In some embodiments, the milk distribution system (28) can distinguish between pumping sessions based on the pre-programmed breast pumping schedule. For example, on the initiation of a new breast pumping session, the breast pump system (1) and/or the milk distribution system (28) can divert the milk flow via a manifold (29) to an empty reservoir (3).

In some embodiments, the method includes pumping milk from the human breast to induce milk from a first breast pumping session to flow from a nipple to the manifold via the breast cup (2); providing fluidic communication between the inlet (30) of the manifold (29) and a first reservoir (3) to allow milk from the first breast pumping session to flow into the first reservoir (3); removing fluidic communication between the inlet (30) of the manifold (29) and the first fluid reservoir (3); pumping the human breast to induce milk from a second breast pumping session to flow from the nipple to the manifold (29) via the breast cup (2); and providing fluidic communication between the inlet (30) of the manifold (29) and a second reservoir (3) to allow milk from the second breast pumping session to flow into the second reservoir (3). In some embodiments, the time between first and second pumping sessions is from about 30 minutes to about 240 minutes (e.g., about 30 minutes to about 45 minutes, about 30 minutes to about 60 minutes, about 30 minutes to about 90 minutes, about 30 minutes to about 120 minutes, about 30 minutes to about 180 minutes, about 45 minutes to about 60 minutes, about 45 minutes to about 90 minutes, about 45 minutes to about 120 minutes, about 60 minutes to about 90 minutes, about 60 minutes to about 120 minutes, about 50 minutes to about 180 minutes, about 60 minutes to about 210 minutes, about 90 minutes to about 120 minutes, about 90 minutes to about 180 minutes, about 90 minutes to about 210 minutes, about 90 minutes to about 240 minutes, about 120 minutes to about 180 minutes, about 120 minutes to about 210 minutes, about 120 minutes to about 240 minutes, about 180 minutes to about 210 minutes, about 180 minutes to about 240 minutes, about 210 minutes to about 240 minutes, about 30 minutes, about 45 minutes, about 60 minutes, about 85 minutes, about 90 minutes, about 105 minutes, about 120 minutes, about 135 minutes, about 150 minutes, about 165 minutes, about 180 minutes, about 195 minutes, about 210 minutes, about 225 minutes, or about 240 minutes).

In some embodiments, the method further includes removing fluidic communication between the inlet (30) of the manifold (29) and the second fluid reservoir (3); and providing fluidic communication between the inlet (30) of the manifold (29) and a third reservoir (3); and pumping the human breast to induce milk from a third breast pumping session to flow from the nipple to the manifold (29) via the breast cup (2). In some embodiments, the time between second and third pumping sessions is from 30 minutes to 240 minutes (e.g., about 30 minutes to about 45 minutes, about 30 minutes to about 60 minutes, about 30 minutes to about 90 minutes, about 30 minutes to about 120 minutes, about 30 minutes to about 180 minutes, about 45 minutes to about 60 minutes, about 45 minutes to about 90 minutes, about 45 minutes to about 120 minutes, about 60 minutes to about 90 minutes, about 60 minutes to about 120 minutes, about 50 minutes to about 180 minutes, about 60 minutes to about 210 minutes, about 90 minutes to about 120 minutes, about 90 minutes to about 180 minutes, about 90 minutes to about 210 minutes, about 90 minutes to about 240 minutes, about 120 minutes to about 180 minutes, about 120 minutes to about 210 minutes, about 120 minutes to about 240 minutes, about 180 minutes to about 210 minutes, about 180 minutes to about 240 minutes, about 210 minutes to about 240 minutes, about 30 minutes, about 45 minutes, about 60 minutes, about 85 minutes, about 90 minutes, about 105 minutes, about 120 minutes, about 135 minutes, about 150 minutes, about 165 minutes, about 180 minutes, about 195 minutes, about 210 minutes, about 225 minutes, or about 240 minutes).

In some embodiments, the method further includes providing fluidic communication between (i) the inlet (31) of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by moving, e.g., rotating, the movable, e.g., rotating, member. In some embodiments, the method further includes removing fluidic communication between (i) the inlet of the manifold and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by moving, e.g., rotating, the moving, e.g., rotating, member. In some embodiments, the moving, e.g., rotating, member rotates clockwise with respect to the stationary member. In some embodiments, the moving, e.g., rotating, member rotates counterclockwise with respect to the stationary member.

In some embodiments, the method further includes providing fluidic communication between (i) the inlet of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by opening the valve to the inlet of the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3). In some embodiments, the method further includes removing fluidic communication between (i) the inlet (30) of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by closing the valve (24) to the inlet of the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3).

In some embodiments, the method further includes providing fluidic communication between (i) the inlet of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by moving the arm. In some embodiments, the method further includes removing fluidic communication between (i) the inlet of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by moving the arm. In some embodiments, the method further includes moving the arm with the drive unit (11), wherein the drive unit (11) is the stepper motor.

In some embodiments, the method further includes turning on the breast pump system (1). The breast pump system (1) may be turned on after the breast cup (2) is contacted to the human breast. In some embodiments, the breast pump system (1) may be turned on before the breast cup (2) is contacted to the human breast, e.g., the negative pressure is applied after the human breast is contacted, or the human breast is contacted during a waiting period before the negative pressure is applied. In some embodiments, breast pump system (1) is turned on with the power switch (14). In some embodiments, the breast pump system (1) is turned on remotely. In some embodiments, the breast pump system (1) is turned on automatically according to a pre-programmed schedule. In some embodiments, the breast pump system (1) is turned on automatically according to a pre-programmed schedule a plurality of times.

In some embodiments, the method further includes turning on a pressure source. A pressure source may be turned on after the breast cup (2) contacts the human breast. In some embodiments, the pressure source is turned on with the power switch (14). In some embodiments, the pressure source is turned on remotely. In some embodiments, the pressure source is turned on automatically according to a pre-programmed schedule. In some embodiments, the pressure source is turned on automatically according to a pre-programmed schedule a plurality of times. The pressure source may be the negative pressure source (9) or a positive pressure source.

In some embodiments, the method further includes turning on the negative pressure source (9).

The negative pressure source (9) may be turned on after the breast cup (2) is contacted to the human breast. In some embodiments, negative pressure source (9) is turned on with the power switch (14). In some embodiments, the negative pressure source (9) is turned on remotely. In some embodiments, the negative pressure source (9) is turned on automatically according to a pre-programmed schedule. In some embodiments, the negative pressure source (9) is turned on automatically according to a pre-programmed schedule a plurality of times.

The first pressure or second pressure may be between about 0 mmHg to about 250 mmHg, e.g., about 0 mmHg to about 10 mmHg, about 0 mmHg to about 20 mmHg, about 0 mmHg to about 30 mmHg, about 0 mmHg to about 40 mmHg, about 0 mmHg to about 50 mmHg, about 0 mmHg to about 60 mmHg, about 0 mmHg to about 70 mmHg, about 0 mmHg to about 80 mmHg, about 0 mmHg to about 90 mmHg, about 0 to about 100 mmHg, about 0 mmHg to about 110 mmHg, about 0 mmHg to about 120 mmHg, about 0 mmHg to about 130 mmHg, about 0 to about 140 mmHg, about 0 mmHg to about 150 mmHg, about 0 to about 175 mmHg, about 0 mmHg to about 200 mmHg, about 0 mmHg to about 225 mmHg, about 0 mmHg to about 250 mmHg, about 0 mmHg to about 275 mmHg, about 0 mmHg to about 300 mmHg, about 0 to about 350 mmHg, about 0 mmHg to about 400 mmHg, about 10 mmHg to about 20 mmHg, about 10 mmHg to about 30 mmHg, about 10 mmHg to about 40 mmHg, about 10 mmHg to about 50 mmHg, about 10 mmHg to about 60 mmHg, about 10 mmHg to about 70 mmHg, about 10 mmHg to about 80 mmHg, about 10 mmHg to about 90 mmHg, about 10 mmHg to about 100 mmHg, about 10 mmHg to about 110 mmHg, about 10 mmHg to about 120 mmHg, about 10 mmHg to about 130 mmHg, about 10 mmHg to about 140 mmHg, about 10 mmHg to about 150 mmHg, about 10 mmHg to about 175 mmHg, about 10 mmHg to about 200 mmHg, about 10 mmHg to about 225 mmHg, about 10 mmHg to about 250 mmHg, about 10 mmHg to about 300 mmHg, about 10 to about 350 mmHg, about 10 mmHg to about 400 mmHg, about 20 mmHg to about 30 mmHg, about 20 mmHg to about 40 mmHg, about 20 mmHg to about 50 mmHg, about 20 mmHg to about 60 mmHg, about 20 mmHg to about 70 mmHg, about 20 mmHg to about 80 mmHg, about 20 mmHg to about 90 mmHg, about 20 mmHg to about 100 mmHg, about 20 mmHg to about 110 mmHg, about 20 mmHg to about 120 mmHg, about 20 mmHg to about 130 mmHg, about 20 mmHg to about 140 mmHg, about 20 mmHg to about 150 mmHg, about 20 mmHg to about 175 mmHg, about 20 mmHg to about 200 mmHg, about 20 mmHg to about 225 mmHg, about 20 mmHg to about 250 mmHg, about 20 mmHg to about 300 mmHg, about 20 to about 350 mmHg, about 20 mmHg to about 400 mmHg, about 25 mmHg to about 50 mmHg, about 25 mmHg to about 75 mmHg, about 25 mmHg to about 100 mmHg, about 30 mmHg to about 40 mmHg, about 30 mmHg to about 50 mmHg, about 30 mmHg to about 60 mmHg, about 30 mmHg to about 70 mmHg, about 30 mmHg to about 80 mmHg, about 30 mmHg to about 90 mmHg, about 30 mmHg to about 100 mmHg, about 30 mmHg to about 110 mmHg, about 30 mmHg to about 120 mmHg, about 30 mmHg to about 130 mmHg, about 30 mmHg to about 140 mmHg, about 30 mmHg to about 150 mmHg, about 30 mmHg to about 175 mmHg, about 30 mmHg to about 200 mmHg, about 30 mmHg to about 225 mmHg, about 30 mmHg to about 250 mmHg, about 30 mmHg to about 300 mmHg, about 30 to about 350 mmHg, about 30 mmHg to about 400 mmHg, about 40 mmHg to about 50 mmHg, about 40 mmHg to about 60 mmHg, about 40 mmHg to about 70 mmHg, about 40 mmHg to about 80 mmHg, about 40 mmHg to about 90 mmHg, about 40 mmHg to about 100 mmHg, about 40 mmHg to about 110 mmHg, about 40 mmHg to about 120 mmHg, about 40 mmHg to about 130 mmHg, about 40 mmHg to about 140 mmHg, about 40 mmHg to about 150 mmHg, about 40 mmHg to about 175 mmHg, about 40 mmHg to about 200 mmHg, about 40 mmHg to about 225 mmHg, about 40 mmHg to about 250 mmHg, about 40 mmHg to about 300 mmHg, about 40 to about 350 mmHg, about 40 mmHg to about 400 mmHg, about 50 mmHg to about 60 mmHg, about 50 mmHg to about 70 mmHg, about 50 mmHg to about 75 mmHg, about 50 mmHg to about 80 mmHg, about 50 mmHg to about 90 mmHg, about 50 mmHg to about 100 mmHg, about 50 mmHg to about 110 mmHg, about 50 mmHg to about 120 mmHg, about 50 mmHg to about 130 mmHg, about mmHg 50 to about 140 mmHg, about 50 mmHg to about 150 mmHg, about 50 mmHg to about 175 mmHg, about 50 mmHg to about 200 mmHg, about 50 mmHg to about 225 mmHg, about 50 mmHg to about 250 mmHg, about 50 mmHg to about 300 mmHg, about 50 to about 350 mmHg, about 50 mmHg to about 400 mmHg, about 60 mmHg to about 70 mmHg, about 60 mmHg to about 80 mmHg, about 60 mmHg to about 90 mmHg, about 60 mmHg to about 100 mmHg, about 60 mmHg to about 110 mmHg, about 60 mmHg to about 120 mmHg, about 60 mmHg to about 130 mmHg, about 60 mmHg to about 140 mmHg, about 60 mmHg to about 150 mmHg, about 60 mmHg to about 175 mmHg, about 60 mmHg to about 200 mmHg, about 60 mmHg to about 225 mmHg, about 60 mmHg to about 250 mmHg, about 60 mmHg to about 300 mmHg, about 60 to about 350 mmHg, about 60 mmHg to about 400 mmHg, about 70 mmHg to about 80 mmHg, about 70 mmHg to about 90 mmHg, about 70 mmHg to about 100 mmHg, about 70 mmHg to about 110 mmHg, about 70 mmHg to about 120 mmHg, about 70 mmHg to about 130 mmHg, about 70 mmHg to about 140 mmHg, about 70 mmHg to about 150 mmHg, about 70 mmHg to about 175 mmHg, about 70 mmHg to about 200 mmHg, about 70 mmHg to about 225 mmHg, about 70 mmHg to about 250 mmHg, about 70 mmHg to about 300 mmHg, about 70 to about 350 mmHg, about 70 mmHg to about 400 mmHg, about 75 mmHg to about 100 mmHg, about 75 mmHg to about 125 mmHg, about 80 mmHg to about 90 mmHg, about 80 mmHg to about 100 mmHg, about 80 mmHg to about 110 mmHg, about 80 mmHg to about 120 mmHg, about 80 mmHg to about 130 mmHg, about 80 mmHg to about 140 mmHg, about 80 mmHg to about 150 mmHg, about 80 mmHg to about 175 mmHg, about 80 mmHg to about 200 mmHg, about 80 mmHg to about 225 mmHg, about 80 mmHg to about 250 mmHg, about 80 mmHg to about 300 mmHg, about 80 to about 350 mmHg, about 80 mmHg to about 400 mmHg, about 90 mmHg to about 100 mmHg, about 90 mmHg to about 110 mmHg, about 90 mmHg to about 120 mmHg, about 90 mmHg to about 130 mmHg, about 90 mmHg to about 140 mmHg, about 90 mmHg to about 150 mmHg, about 90 mmHg to about 175 mmHg, about 90 mmHg to about 200 mmHg, about 90 mmHg to about 225 mmHg, about 90 mmHg to about 250 mmHg, about 90 mmHg to about 300 mmHg, about 90 to about 350 mmHg, about 90 mmHg to about 400 mmHg, about 100 mmHg to about 110 mmHg, about 100 mmHg to about 120 mmHg, about 100 mmHg to about 130 mmHg, about 100 mmHg to about 140 mmHg, about 100 mmHg to about 150 mmHg, about 100 mmHg to about 175 mmHg, about 100 mmHg to about 200 mmHg, about 100 mmHg to about 225 mmHg, about 100 mmHg to about 250 mmHg, about 100 mmHg to about 300 mmHg, about 100 to about 350 mmHg, about 100 mmHg to about 400 mmHg, about 110 mmHg to about 120 mmHg, about 110 mmHg to about 130 mmHg, about 110 mmHg to about 140 mmHg, about 110 mmHg to about 150 mmHg, about 110 mmHg to about 175 mmHg, about 110 mmHg to about 200 mmHg, about 110 mmHg to about 225 mmHg, about 110 mmHg to about 250 mmHg, about 110 mmHg to about 300 mmHg, about 110 to about 350 mmHg, about 110 mmHg to about 400 mmHg, about 120 mmHg to about 130 mmHg, about 120 mmHg to about 140 mmHg, about 120 mmHg to about 150 mmHg, about 120 mmHg to about 175 mmHg, about 120 mmHg to about 200 mmHg, about 120 mmHg to about 225 mmHg, about 120 mmHg to about 250 mmHg, about 120 mmHg to about 300 mmHg, about 120 to about 350 mmHg, about 120 mmHg to about 400 mmHg, about 130 mmHg to about 140 mmHg, about 130 mmHg to about 150 mmHg, about 130 mmHg to about 175 mmHg, about 130 mmHg to about 200 mmHg, about 130 mmHg to about 225 mmHg, about 130 mmHg to about 250 mmHg, about 130 mmHg to about 300 mmHg, about 130 to about 350 mmHg, about 130 mmHg to about 400 mmHg, about 140 mmHg to about 150 mmHg, about 140 mmHg to about 175 mmHg, about 140 mmHg to about 200 mmHg, about 140 mmHg to about 225 mmHg, about 140 mmHg to about 250 mmHg, about 140 mmHg to about 300 mmHg, about 140 to about 350 mmHg, about 140 mmHg to about 400 mmHg, about 150 mmHg to about 175 mmHg, about 150 mmHg to about 200 mmHg, about 150 mmHg to about 225 mmHg, about 150 mmHg to about 250 mmHg, about 150 mmHg to about 300 mmHg, about 150 to about 350 mmHg, about 150 mmHg to about 400 mmHg, about 175 mmHg to about 200 mmHg, about 175 mmHg to about 225 mmHg, about 175 mmHg to about 250 mmHg, about 175 mmHg to about 300 mmHg, about 175 to about 350 mmHg, about 175 mmHg to about 400 mmHg, about 200 mmHg to about 225 mmHg, about 200 mmHg to about 250 mmHg, about 200 mmHg to about 300 mmHg, about 200 to about 350 mmHg, about 200 mmHg to about 400 mmHg, about 225 mmHg to about 250 mmHg, about 225 mmHg to about 300 mmHg, about 225 to about 350 mmHg, about 225 mmHg to about 400 mmHg, about 275 mmHg to about 300 mmHg, about 275 to about 350 mmHg, about 275 mmHg to about 400 mmHg, about 300 mmHg to about 325 mmHg, about 300 to about 350 mmHg, about 300 mmHg to about 400 mmHg, about 325 mmHg to about 350 mmHg, about 325 to about 375 mmHg, about 325 mmHg to about 400 mmHg, about 350 mmHg to about 375 mmHg, about 350 to about 400 mmHg, or about 375 mmHg to about 400 mmHg.

The breast pump system (1) may pump from about 1 second to about 2 hours, about e.g., about seconds to about 1 minute, about 30 seconds to about 2 minutes, about 30 seconds to about 3 30 minutes, about 30 seconds to about 4 minutes, about 30 seconds to about 5 minutes, about 30 seconds to about 10 minutes, about 30 seconds to about 15 minutes, about 30 seconds to about 30 minutes, about 30 seconds to about 5 minutes, about 5 minutes to about 10 minutes, about 5 minutes to about 15 minutes, about 5 minutes to about 20 minutes, about 5 minutes to about 25 minutes, about 5 minutes to about 30 minutes, about 5 minutes to about 35 minutes, about 5 minutes to about 40 minutes, about 5 minutes to about 1 hour, about 10 minutes to about 15 minutes, about 10 minutes to about 20 minutes, about 10 minutes to about 25 minutes, about 10 minutes to about 30 minutes, about 10 minutes to about 40 minutes, about 10 minutes to about 50 minutes, about 10 minutes to about 1 hour, about 15 minutes to about 30 minutes, about 15 minutes to about 45 minutes, about 15 minutes to about 1 hour, about 15 minutes to about 1.25 hours, about 15 minutes to about 1.5 hours, about 15 minutes to about 1.75 hours, about 15 minutes to about 2 hours, about 20 minutes to about 30 minutes, about 20 minutes to about 40 minutes, about 20 minutes to about 50 minutes, about 30 minutes to about 45 minutes, about 30 minutes to about 1 hour, about 30 minutes to about 1.25 hours, about 30 minutes to about 1.5 hours, about 30 minutes to about 1.75 hours, about 30 minutes to about 2 hours, about 45 minutes to about 1 hour, about 45 minutes to about 1.25 hours, about 45 minutes to about 1.5 hours, about 45 minutes to about 1.75 hours, about 45 minutes to about 2 hours, about 1 hour to about 1.25 hours, about 1 hour to about 1.5 hours, about 1 hour to about 1.75 hours, about 1 hour to about 2 hours, about 1.25 hours to about 1.5 hours, about 1.25 hours to about 1.75 hours, about 1.25 hours to about 2 hours, about 1.5 hours to about 1.75 hours, about 1.5 hours to about 2 hours, or about 1.75 hours to about 2 hours. The user may input a pump program from about 1 second to about 2 hours, and, e.g., set the program before the start of an activity, rest, or sleep.

In some embodiments, the method further includes turning on a positive pressure source. A positive pressure source may be turned on after the breast cup (2) contacts the human breast. In some embodiments, the positive pressure source is turned on with the power switch (14). In some embodiments, the positive pressure source is turned on remotely. In some embodiments, the positive pressure source is turned on automatically according to a pre-programmed schedule. In some embodiments, the positive pressure source is turned on automatically according to a pre-programmed schedule a plurality of times.

In some embodiments, the method further includes turning off the breast pump system (1). In some embodiments, the breast pump system (1) is turned off with the power switch (14). In some embodiments, the breast pump system (1) is turned off remotely. In some embodiments, the breast pump system (1) is turned off automatically according to a pre-programmed schedule. In some embodiments, the breast pump system (1) is turned off automatically according to a pre-programmed schedule a plurality of times.

In some embodiments, the method further includes turning off the negative pressure source (9). In some embodiments, the negative pressure source (9) is turned off with the power switch (14). In some embodiments, the negative pressure source (9) is turned off remotely. In some embodiments, the negative pressure source (9) is turned off automatically according to a pre-programmed schedule. In some embodiments, the negative pressure source (9) is turned off automatically according to a pre-programmed schedule a plurality of times.

The method may include alternating between a first pressure to extend the nipple and express milk, and a second pressure to contact the nipple and slow or stop milk expression. Additionally, the method may include pumping at from two to ten pressures, e.g., one, two, three, four, five, six, seven, eight, nine, or ten pressures. The pressures applied to the breast may increase or decrease throughout the pumping.

In some embodiments, the method includes placing an ice pack in the enclosure (4). In some embodiments, the method includes removing the ice pack from the enclosure (4). In some embodiments, the method includes placing the ice pack in a freezer.

As discussed above, the breast pump system (1) may include at least one sensor. The method may further include the taking of a weight, temperature, pressure, pH, viscosity, optical, volume, or flow measurement. The method may further include alerting a user of a sensor measurement. The method may further include changing at least one of the first pressure or second pressure based on the temperature, weight, pressure, or flow measurement.

The present disclosure provides methods of breast pumping while the user is in motion.

If mothers prioritize a return to their daily routine, e.g., work, the possibility of not initiating or prematurely ending the breastfeeding period may increase. The present disclosure provides breast pump systems (1) which may be used while the user is in motion, such that the user may consistently breast pump while prioritizing their daily routine. The present disclosure further provides breast pump systems (1) which may be used while the user is working.

The present disclosure provides methods of breast pumping while resting or sleeping.

If mothers prioritize sleep, the possibility of not initiating or prematurely ending the breastfeeding period may increase. It has been found that nearly 75% of sleep disruption in mothers was caused by breastfeeding. The present disclosure provides breast pump systems (1) which may be used during rest or sleep, thus allowing mothers to pump for a longer time post-birth while still prioritizing sleep.

The disclosure further provides methods of cleaning a breast pump system, including providing the breast pump system (1), providing a cleaning fluid to breast cup (2); and pumping the cleaning fluid from the breast cup (2) to the reservoir (3) or waste.

The present invention provides a method of distributing milk from breast pumping, including: (i) providing the milk distribution system (28) of the present disclosure; (ii) pumping a human breast to induce milk from a first breast pumping session to flow from a nipple to the manifold (29) via the breast cup (2); (iii) providing fluidic communication between the inlet (30) of the manifold (29) and a first reservoir (3) to allow milk from the first breast pumping session to flow into the first reservoir (3); (iv) removing fluidic communication between the inlet (30) of the manifold (29) and the first fluid reservoir (3); (v) pumping the human breast to induce milk from a second breast pumping session to flow from the nipple to the manifold (29) via the breast cup (2); and (vi) providing fluidic communication between the inlet (30) of the manifold (29) and a second reservoir (3) to allow milk from the second breast pumping session to flow into the second reservoir (3).

In some embodiments, providing fluidic communication between the inlet (30) of the manifold (29) and the first reservoir (3) includes opening a first valve (24). In some embodiments, the control unit sends a signal to the first valve (24) to open and/or close. In some embodiments, the control unit sends a signal to the second valve (24) to open and/or close.

In some embodiments, the time between step (ii) and step (v) is from about 30 minutes to about 240 minutes (e.g., 30 minutes to 60 minutes, 30 minutes to 90 minutes, 60 minutes to 90 minutes, about 60 minutes to about 120 minutes, about 60 minutes to about 180 minutes, about 90 minutes to about 180 minutes, about 90 minutes to about 240 minutes, or about 120 minutes to about 240 minutes).

In some embodiments, the method further includes (vi) removing fluidic communication between the inlet (30) of the manifold (29) and the second fluid reservoir (3); and (vii) providing fluidic communication between the inlet (30) of the manifold (29) and a third reservoir (3); and (viii) pumping the human breast to induce milk from a third breast pumping session to flow from the nipple to the manifold (29) via the breast cup (2). In some embodiments, the time between step (v) and step (viii) is from 30 minutes to 240 minutes.

In some embodiments, the method further includes providing fluidic communication between (i) the inlet (30) of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by moving, e.g., rotating, the moving, e.g., rotating, member. In some embodiments, the method further includes removing fluidic communication between (i) the inlet (30) of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by moving, e.g., rotating, the moving, e.g., rotating, member.

In some embodiments, the method further includes providing fluidic communication between (i) the inlet (30) of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by opening the valve (24) to the inlet of the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3). In some embodiments, the method further includes removing fluidic communication between (i) the inlet (30) of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by closing the valve (24) to the inlet of the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3).

In some embodiments, the method further includes providing fluidic communication between (i) the inlet (30) of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by moving the arm. In some embodiments, the method further includes removing fluidic communication between (i) the inlet (30) of the manifold (29) and (ii) the first reservoir (3), the second reservoir (3), or the third fluid reservoir (3) by moving the arm. In some embodiments, the method further includes moving the arm with the drive unit (11), wherein the drive unit (11) is the stepper motor.

In some embodiments, a subject including the human breast is moving, reclining, resting, or sleeping.

Kits

In another aspect, the disclosure provides kits. Kits may include two or more unconnected components of a breast pump system or a breast cup. A kit may include a breast cup or components thereof and one or more fluidic conduits. For example, a kit may include two breast cups or components thereof and two or more fluidic conduits. The fluidic conduits, e.g., for the pressure chamber and/or the milk chamber, may be branched to allow connection to both breast cups with a single connection to the pressure source or reservoir or milk distribution system. A kit including components of a breast cup may include at least two of the following components, e.g., all: the housing (17), the diaphragm (18), the breast shield (19), and the milk chamber wall (26). A user may assemble the breast cup from the kit. A kit may include two or more components of the breast pump system, e.g., one or more breast cups, a pressure source, a milk distribution system, and a reservoir.

EXAMPLES Example 1 Exemplary Breast Pump System

Example 1 presents an exemplary embodiment of a breast pump system (1) having the components and arrangement as shown in the schematic of FIG. 16A.

FIG. 1 shows an exemplary a breast pump system (1), including a pump housing (7), a power switch (14), two breast cups (2), and two fluid conduits (5). FIG. 8A-8C shows the internal components of the breast pump system (1) of FIG. 1 , including a negative pressure source (9), a control valve (10), a drive unit (11), a first power source (12), a second power source (16), and a power switch (14).

The pumping housing (7) is in fluidic communication with the breast cups (2) via the first fluid conduit (5) and the second fluid conduit (5). The breast cups (2) can be placed on the breasts of a user prior to breast pumping. An exemplary breast cup (2) can be seen in FIG. 14 , having a wide portion (8) and a nipple tunnel (13).

The first fluid conduit (5) and second fluid conduit (5) also place the breast cup (2) in fluidic communication with a reservoir (3) in a reservoir enclosure (4). FIG. 15 shows an exemplary reservoir enclosure (4) including a reservoir (3) containing breast milk. The reservoir (3) of FIG. 15 includes a one directional valve (15), such that milk may not backflow from the reservoir (3).

The breast pump system (1) includes controls that are operable by a user to select or modify at least one of: pumping program or mode, frequency of pumping cycle, maximum suction pressure achieved during a pumping cycle, latch suction pressure achieved during the pumping cycle, pumping force and pumping session time. The controls are present in an application on an external computer.

In the application, the user is able to set the pump programing including pumping length, cycle speed(s), vacuum level(s), and pump start time(s). The breast pump system (1) has two phases: a stimulation phase and an expression phase. The stimulation phase is typically characterized by a rapid initial stage, e.g., 100 cycles per minute, at a low to moderate vacuum strength. The initial rapid stage induces the letdown of milk and mimics the initial quick suckling motion of an infant. Once milk begins flowing, the system or the user typically switches the breast pump system (1) into the expression phase. Expression is typically characterized by slower cycles per minute, e.g., 38 cycles per minute, at moderate to high vacuum strength. The expression phase mimics an infant's behavior at breast with slower and deeper suckling. It is possible for the user to cycle between these two phases more than one time per session. Once a user has completed the initial stimulation and expression phase, the user may switch back to stimulation mode to produce another let down of milk and then begin another expression cycle.

Example 2 Exemplary Breast Cup

Example 2 presents an exemplary embodiment of the breast cup (2) having the components and arrangement as shown in the schematic of FIG. 17 .

FIG. 17 shows an exemplary breast cup (2) including housing (17), diaphragm (18), breast shield (19), pressure chamber (20), milk chamber (21), outlet (22), and sealing point (23).

When negative pressure is applied to pressure chamber (20), diaphragm (18) deforms away sealing point (23), opening the inlet to milk chamber (21). As negative pressure is applied to the nipple, the nipple expands, and milk is expressed. The expressed milk enters milk chamber (21) through the opened inlet, expanding the volume of milk chamber (21).

Optionally, a control valve may be opened to return the pressure of breast shield (19) to atmospheric pressure, allowing the nipple to return to a nominal length, and allowing the diaphragm to return to a position sealing the inlet to milk chamber (21) at sealing point (23).

When positive pressure is applied to pressure chamber (2), diaphragm (18) deforms towards sealing point (23), sealing the inlet to milk chamber (21) at sealing point (23). Diaphragm (18) further deforms towards milk chamber (21), transporting milk through outlet (22) of milk chamber (21), and into a fluid conduit. Milk then flows towards a reservoir.

Example 3 Exemplary Wireless Use of Breast Pump System

Example 3 presents demonstrates a protocol for wireless use of the presently disclosed breast pump system.

Turning the Device On/Off

Press the power button on the top of the housing. Check if the breast pump system is on if the system is indicating an ability to wirelessly connect.

Wirelessly Connecting the Device

Download a compatible application on a cellular device. Open the application. Connect the application to the breast pump system.

Starting the Pump/Timer

From the application screen, set the timer to a desired wait time and a desired pumping time. The wait time is the time before the breast pump begins pumping, allowing the user to contact the breast with the breast cup. The pump time is the length of time the breast pump system will pump before turning off.

Stopping the Pump/Timer

From the application screen, stop the timer. A stop of the timer will stop both the wait time and the pump if it is running.

Setting the Vacuum Level

From the application screen, set a vacuum level, entering a number between 0-100, which correlates to the percentage power the pump will run at.

Setting a Pump Program

From the application screen, create a pump program. From the pump program screen select pumping length in minutes, cycle speed(s), vacuum level(s), and pump start time(s).

Table 1 shows an example of a pre-programmed pumping profile.

A Pump program may include a number of minutes the pump will be used for, the cycle speed, and vacuum level.

TABLE 1 Time (Minutes) Cycle Level 2 70 3 to 4 8 50 4 to 7 2 70 4 to 5 3 46 6 to 8 5 42 6 to 8 2 70 4 to 5 3 to 8 38 6 to 10

Checking Milk Temperature

Check the application program for the current temperature of the milk in the reservoir.

Checking Milk Volume

Check the application program for the current volume of milk produced and/or percent full of the reservoir, e.g., from 0% to 100% full.

Device Power/Charging

The pump has two separate battery supplies. The first battery is electrically connected to the control unit. The first battery is charged by plugging the breast pump system into an AC wall outlet. The second battery, a set of 8 AA batteries, is electrically connected to the drive unit. Replace the AA batteries when drained.

Checking Pump Settings

Check the application program for time left in the pump program and current vacuum level.

Updating Breast Pump System Software

Open the application settings and initiate a software update. In some instances, a notification will alert a user to the availability of a new software update.

Cleaning the Breast Pump System

To clean the breast pump system, remove the breast cups and open the end of the reservoir bag into the sink. Place the tubes that connect to the breast cups in a bowl of water. Start the timer and let the breast pump system run for a period of time to flush water through the system. Remove the tubing from the bowl of water and allow air to flush through the system.

Example 4

A breast cup (2) including a milk chamber wall (26) is shown in FIGS. 26A-26D. As shown in FIG. 26A, the breast cup (2) includes a breast shield (19), a milk chamber wall (26), a diaphragm (18), and a housing (17). The milk chamber (21) is disposed between the diaphragm and the milk chamber wall, and the pressure chamber is disposed between the housing and the diaphragm. The diaphragm includes two portions, a more rigid portion that seals against the end of the nipple tunnel and a more flexible portion surrounding the more rigid portion. The milk chamber and pressure chamber have ports that connect to fluid conduits. The ports are on opposite sides of the breast cup from each other. The breast cup includes a one directional valve (15) to allow milk to leave the milk chamber and to prevent backflow from a reservoir. The breast shield includes a lip at the periphery that mates with the periphery of the milk chamber wall. The diaphragm includes ridges that mate with grooves in the housing and milk chamber wall. The milk chamber wall, diaphragm, and housing are held together by fasteners. The breast cup may be disassembled for cleaning or replacement of components.

Example 5

A milk distribution system is shown in FIGS. 27A-27B. The milk distribution system (28) includes an inlet (30) to connect to a fluid conduit from a breast cup. The inlet is fluidly connected to an alignment plate (33) having an outlet (31). The alignment plate is rotated between four inlets in a manifold. The manifold has four arms and is made up of top and bottom plates sealed with a gasket (36). The bottom plate includes four channels, each terminating at an outlet. The outlet includes an O-ring on the exterior to mate with the inlet to a reservoir, e.g., milk bottle. A stepper motor (39) connected to a drive dog (37) rotates the alignment plate between the inlets in the manifold. The milk distribution system further includes a vertical body (35) to support the inlet, alignment plate, manifold, motor, and drive dog. The milk distribution system also includes a weighing plate (34) on which up to four reservoirs may rest. The base also includes a weight sensor to measure the weight on the weighing plate. The milk distribution system further includes a stationary base (38) to support the other components.

Milk is delivered via the inlet to the alignment plate, the outlet of which is aligned with one of the four inlets of the manifold. Milk then flows through the channel in the manifold and into a reservoir. The weight sensor can be used to determine the amount of milk delivered to a reservoir. Once a pumping cycle is complete, the system may rotate the alignment to the next, empty reservoir or to an intermediate position between manifold inlets. Reservoirs are sealed when the alignment plate is not aligned with the manifold inlet to which it is connected.

Example 6

FIG. 28 shows a milk distribution system (28) that includes a flush line connected to a fluid conduit (5). One directional valves prevent back flow when either milk or flush air is being drawn into the conduit. The manifold (29) connects to one of the reservoirs (3). A vacuum, which can be the same as the one coupled to the pressure chamber (9) or a separate pump (32), reduces pressure in the reservoir (3) being filled. A vent may be present to release vacuum when the flush is complete.

Other embodiments are in the claims. 

1. A breast cup comprising: (a) a housing; (b) a breast shield; (c) a diaphragm disposed between the housing and the breast shield, wherein the diaphragm is disposed between a pressure chamber and a milk chamber.
 2. The breast cup of claim 1, wherein the breast shield comprises a wide portion and a nipple tunnel.
 3. The breast cup of claim 1, further comprising a milk chamber wall disposed between the diaphragm and the breast shield, wherein the diaphragm and the milk chamber wall define the milk chamber.
 4. The breast cup of claim 1, wherein the milk chamber comprises an inlet from the breast shield, and the diaphragm releasably seals the inlet.
 5. The breast cup of claim 4, wherein the inlet comprises a valve.
 6. The breast cup of claim 5, wherein the valve is a mechanical valve, an umbrella valve, a butterfly valve, a disk valve, or a duckbill valve.
 7. The breast cup of claim 4, wherein the inlet comprises a plurality of orifices.
 8. The breast cup of claim 7, wherein the plurality of orifices is circumferentially arranged at a nipple tunnel of the breast shield.
 9. The breast cup of claim 1, wherein the breast shield and/or the housing comprises ridges, bumps or dimples.
 10. The breast cup of claim 1, wherein the breast shield comprises a toroidal ridge.
 11. The breast cup of claim 1, wherein the diaphragm comprises a material having a shore harness from A10 to A80 or D10 to D80.
 12. The breast cup of claim 4, wherein the diaphragm comprises a first material and a second material, where the second material is more rigid than the first material and seals the inlet.
 13. The breast cup of claim 1, wherein the housing, diaphragm, and/or breast shield comprises a clear material.
 14. The breast cup of claim 13, wherein the clear material forms a magnifying lens.
 15. The breast cup of claim 13, wherein the diaphragm comprises the clear material where the diaphragm contacts an inlet to the milk chamber.
 16. The breast cup of claim 1, wherein the diaphragm is shaped to conform to the shape of the housing or breast shield.
 17. The breast cup of claim 1, wherein the milk chamber further comprises an outlet.
 18. The breast cup of claim 17, further comprising a one directional valve configured to allow fluid flow from the milk chamber to a reservoir.
 19. The breast cup of claim 18, wherein the one directional valve is disposed in the outlet.
 20. A breast pump system comprising: (a) a breast cup of claim 1; and (b) a negative pressure source, wherein the negative pressure source is fluidic communication with the pressure chamber.
 21. The breast pump system of claim 20, further comprising a positive pressure source, wherein the positive pressure source is in fluidic communication with the pressure chamber.
 22. The breast pump system of claim 20, further comprising a first fluid conduit providing fluidic communication between the milk chamber and a reservoir.
 23. (canceled)
 24. The breast pump system of claim 20, further comprising a second fluid conduit providing fluidic communication between the negative pressure source and the pressure chamber. 25.-27. (canceled)
 28. The breast pump system of claim 20, further comprising a second breast cup comprising: (a) a housing; (b) a breast shield; (c) a diaphragm disposed between the housing and the breast shield, wherein the diaphragm is disposed between a pressure chamber and a milk chamber.
 29. The breast pump system of claim 20, further comprising a reservoir in fluidic communication with the milk chamber.
 30. The breast pump system of claim 20, further comprising a plurality of reservoirs.
 31. The breast pump system of claim 30, further comprising a pressure outlet in fluidic communication with each reservoir. 32.-47. (canceled)
 48. The breast pump system of claim 20, further comprising a reservoir enclosure.
 49. The breast pump system of claim 48, wherein the enclosure comprises a cooling element and/or insulation.
 50. The breast pump system of claim 48, wherein the reservoir enclosure includes a weight sensor. 51.-64. (canceled) 